{"id":676,"date":"2025-07-30T07:21:09","date_gmt":"2025-07-30T07:21:09","guid":{"rendered":"http:\/\/mdx.local\/?post_type=service&#038;p=676"},"modified":"2026-03-09T13:38:15","modified_gmt":"2026-03-09T13:38:15","slug":"training-consultancy","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/fr\/services\/training-consultancy\/","title":{"rendered":"Training &amp; Consultancy"},"content":{"rendered":"\n<section id=\"block_a7e53f672faf37037403eac87abdae40\" class=\"hero hero--grayscale\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/partner.jpg\" fetchpriority=\"high\" class=\"no-lazy\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Medical Device &#038; IVD Regulatory Training and Consulting<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">From FDA submissions and IVDR\/MDR compliance to quality systems implementation and QMS training-our former notified body experts deliver practical knowledge that builds capabilities, ensures compliance, and accelerates your path to market.<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/contact\/?utm_source=training_consultancy\" class=\"button button--default\" target=\"_self\">\n                            Book a Consulting Session                        <\/a>\n                                            <a href=\"#popular-training\" class=\"button button--secondary\" target=\"_self\">\n                            View Popular Training                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_9cfd583cf2f013bf0dcebb8bea4d62b5\" class=\"sticky-navbar\" style=\"\">\n                <div class=\"container\">\n                <ul class=\"list\">\n                    <li class=\"item\">\n                            <a href=\"#Training\" class=\"link\" target=\"\"> \n                    Training  \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Consulting\" class=\"link\" target=\"\"> \n                    Consulting \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Case-Studies\" class=\"link\" target=\"\"> \n                    Case Studies \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#popular-training\" class=\"link\" target=\"\"> \n                    Workshops \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#FAQs\" class=\"link\" target=\"\"> \n                     FAQs \n                <\/a>\n                            <\/ul>\n                \n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_4e4072f20cbad2dd51d1f658096ba99b\" class=\"text-image\" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Transform Regulatory Complexity Into Strategic Advantage<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">In today&rsquo;s evolving medical device and IVD regulatory landscape, having access to specialized knowledge is your competitive edge. <\/span><b>MDx CRO delivers targeted training and expert consulting services that build internal capabilities, strengthen compliance strategies, and drive successful regulatory outcomes.<\/b><\/p>\n<p><span style=\"font-weight: 400\">Whether you need hands-on FDA submission support, expert guidance for MDR\/IVDR transition, or comprehensive quality systems implementation, our customizable training and consulting solutions deliver practical, implementation-focused expertise that transforms compliance challenges into market opportunities. Led by former notified body and regulatory authority experts, our services accelerate your path to market while minimizing regulatory risks.<\/span><\/p>\n<p><b>Trusted by Notified Bodies<\/b><span style=\"font-weight: 400\">: As the selected training partner for multiple European Notified Bodies, MDx regularly trains the very authorities responsible for IVDR and MDR conformity assessments-a testament to our unparalleled regulatory expertise and teaching capabilities.<\/span><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/c09b57f3ff74a76f185f5cd949ca1825498d2359.jpg\" alt=\"\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"Training\" class=\"content-columns content-columns--three-columns \" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--small); \">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Our Training Portfolio<\/h2>\n                                                    <div class=\"description wysiwyg\">\n                        <p><b>Regulatory Frameworks &amp; Standards Training<\/b><\/p>\n                    <\/div>\n                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">EU Regulatory Training<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><b>IVDR 2017\/746 Workshops<\/b><span style=\"font-weight: 400\"> \u2013 Classification, performance evaluation, and technical documentation<\/span><\/li>\n<li style=\"font-weight: 400\"><b>MDR 2017\/745 Implementation<\/b><span style=\"font-weight: 400\"> \u2013<\/span><a href=\"https:\/\/mdxcro.com\/fr\/sectors\/medical-devices\/\"><span style=\"font-weight: 400\"> Clinical evaluation<\/span><\/a><span style=\"font-weight: 400\">, QMS integration, and post-market requirements<\/span><\/li>\n<li style=\"font-weight: 400\"><b>EUDAMED &amp; UDI Compliance<\/b><span style=\"font-weight: 400\"> \u2013 Registration procedures and data submission requirements<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Economic Operator Training<\/b><span style=\"font-weight: 400\"> \u2013 Importer, distributor, and PRRC responsibilities<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">FDA &#038; Global Pathways<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><b>FDA Regulatory Requirements<\/b><span style=\"font-weight: 400\"> \u2013 510(k), De Novo, PMA pathways and Q-submission strategies<\/span><\/li>\n<li style=\"font-weight: 400\"><b>FDA Pre-Submission Consulting<\/b><span style=\"font-weight: 400\"> \u2013 Meeting preparation and optimal documentation<\/span><\/li>\n<li style=\"font-weight: 400\"><b>UKCA Marking<\/b><span style=\"font-weight: 400\"> \u2013 Post-Brexit requirements and transition planning<\/span><\/li>\n<li style=\"font-weight: 400\"><b>International Registration Strategies<\/b><span style=\"font-weight: 400\"> \u2013 Multi-country regulatory approaches<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Quality &#038; Standards Mastery<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><b>ISO 13485:2016<\/b><span style=\"font-weight: 400\"> \u2013 QMS implementation, documentation, and audit preparation<\/span><\/li>\n<li style=\"font-weight: 400\"><b>ISO 14971:2019<\/b><span style=\"font-weight: 400\"> \u2013 Risk management principles and documentation<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Good Clinical Practice Training<\/b><span style=\"font-weight: 400\"> \u2013 Adapted for medical device and IVD trials<\/span><\/li>\n<li style=\"font-weight: 400\"><b>ISO 20916:2024<\/b><span style=\"font-weight: 400\"> \u2013 <\/span><a href=\"https:\/\/mdxcro.com\/fr\/services\/ivd-clinical-studies\/\"><span style=\"font-weight: 400\">Clinical performance studies for IVDs<\/span><\/a><\/li>\n<li style=\"font-weight: 400\"><b>ISO 14155:2020<\/b><span style=\"font-weight: 400\"> \u2013 Clinical investigations for medical devices<\/span><\/li>\n<li style=\"font-weight: 400\"><b>IEC 62304<\/b> \u2013 Software lifecycle requirements and validation<\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n\n<section class=\"table\"><div class=\"container\"><div class=\"headline\">Training Delivery Models Tailored to Your Organization&rsquo;s Needs<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Format<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>Onsite Workshops<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Virtual Training<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Hybrid Programs<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Train-the-Trainer<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Executive Briefings<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Custom Consulting<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">Description<\/th><th class=\"column\">Best For<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\">Hands-on, interactive sessions at your facility with practical exercises and implementation focus<\/td><td class=\"cell\">Cross-functional teams requiring immersive learning<\/td><\/tr><tr><td class=\"cell highlight\">Live, instructor-led sessions with interactive components and digital materials<\/td><td class=\"cell\">Distributed teams or flexible scheduling needs<\/td><\/tr><tr><td class=\"cell highlight\">Combination of self-paced learning and live sessions<\/td><td class=\"cell\">Comprehensive programs requiring different learning modes<\/td><\/tr><tr><td class=\"cell highlight\">Intensive programs to develop internal training capabilities<\/td><td class=\"cell\">Organizations building sustainable internal expertise<\/td><\/tr><tr><td class=\"cell highlight\">Concise, strategic sessions for leadership<\/td><td class=\"cell\">C-suite and senior management decision-making<\/td><\/tr><tr><td class=\"cell highlight\">Targeted expertise to solve specific challenges<\/td><td class=\"cell\">Addressing immediate regulatory or quality gaps<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n\n\n<section id=\"block_e3daf8110b35526ca3db9efc152b34d8\" class=\"flip-cards flip-cards--three-columns flip-cards--card-size-small \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Our Training Methodology<\/h2>\n            \n            \n                            <div class=\"description wysiwyg\"><p><span style=\"font-weight: 400;\">MDx delivers a comprehensive learning experience that transforms theory into practical implementation:<\/span><\/p>\n<\/div>\n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-blue card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">1.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Pre-Assessment<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Understanding your team&rsquo;s knowledge baseline and specific challenges<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">2.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Customization<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Tailoring materials to your products, processes, and regulatory goals<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">3.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Interactive Learning<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Case studies, workshops, and problem-solving exercises<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">4.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Knowledge Assessment<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Verification of understanding and competence<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">5.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Implementation Support<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Post-training assistance with applying concepts<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">6.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Continuous Improvement<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Follow-up and refresher options for sustained skills development<\/span><\/p>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n\n\n<section id=\"Consulting\" class=\"content-columns content-columns--four-columns \" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Consulting Approaches<\/h2>\n                                                    <div class=\"description wysiwyg\">\n                        <p><b>Strategic Support for Every Regulatory Challenge<\/b><\/p>\n                    <\/div>\n                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">On-Demand Expert Access<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Rapid answers to critical regulatory questions<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Direct access to former notified body and FDA experts<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Flexible consulting arrangements tailored to project needs<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Technical Documentation Review<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Gap assessment and remediation<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Pre-submission evaluation<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Mock notified body reviews<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">FDA submission readiness assessment<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Strategic Planning &#038; Implementation<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Regulatory roadmap development<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Transition planning for new regulations<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Resource planning and timeline development<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Cross-functional implementation support<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Fractional Regulatory Support<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Part-time PRRC services<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Interim regulatory affairs leadership<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Outsourced regulatory operations<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Submission management and follow-up<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_540f22ffd468aaec150e4b9702edbf44\" class=\"tabs\">\n        <div class=\"container\">\n                    <div class=\"title\">Specialized Consulting Services<\/div>\n            <\/div>\n\n    <div class=\"tabs-wrapper\">\n        <!-- Tab Navigation -->\n        <div class=\"tab-navigation\">\n                            <button class=\"tab-button active\" data-tab=\"fda-submission-support\">\n                    FDA Submission Support                <\/button>\n                            <button class=\"tab-button\" data-tab=\"eu-regulatory-strategy\">\n                    EU Regulatory Strategy                <\/button>\n                            <button class=\"tab-button\" data-tab=\"quality-compliance\">\n                    Quality &amp; Compliance                <\/button>\n                            <button class=\"tab-button\" data-tab=\"specialized-expertise\">\n                    Specialized Expertise                <\/button>\n                    <\/div>\n\n        <!-- Tab Content -->\n        <div class=\"tab-content-wrapper\">\n                            <div class=\"tab-content active\" id=\"fda-submission-support\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>FDA Submission Support<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li><b>510(k) Submission Consulting<\/b>\u00a0\u2013 Pathway determination, substantial equivalence<\/li>\n<li><b>Q-submission Strategy<\/b>\u00a0\u2013 Pre-submission meeting preparation and execution<\/li>\n<li><b>Response Management<\/b>\u00a0\u2013 Additional information requests and deficiency letters<\/li>\n<li><b>FDA Regulatory Consulting<\/b>\u00a0\u2013 Product classification, regulatory strategy<\/li>\n<\/ul>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/technical-documentation.jpg\" alt=\"Magnifying glass focusing on a document with awards and certification icons, representing MedTech innovation, quality assurance, and product development in healthcare technology.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to FDA Submission Support                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"eu-regulatory-strategy\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>EU Regulatory Strategy<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li><b>MDR\/IVDR Gap Assessment<\/b>\u00a0\u2013\u00a0<a href=\"https:\/\/mdxcro.com\/fr\/services\/regulatory-affairs-technical-documentation\/\">Technical documentation<\/a>\u00a0and process evaluation<\/li>\n<li><b>CE Marking Strategy<\/b>\u00a0\u2013 Conformity assessment planning<\/li>\n<li><b>Classification Consulting<\/b>\u00a0\u2013 Product qualification and rule interpretation<\/li>\n<li><b>Notified Body Selection<\/b>\u00a0\u2013 Matching your needs with optimal NB expertise<\/li>\n<\/ul>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Untitled-96.jpg\" alt=\"Europe flag flying in front of a modern glass building, symbolizing EU leadership and innovation in MedTech industry, highlighting the impact of the EU on accelerating medical technology advancements.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to EU Regulatory Strategy                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"quality-compliance\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Quality &amp; Compliance<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li><a href=\"https:\/\/mdxcro.com\/fr\/services\/quality-risk-audit\/\"><b>Quality System Implementation<\/b><\/a>\u00a0\u2013 ISO 13485 and FDA QSR<\/li>\n<li><b>Medical Device Compliance Consulting<\/b>\u00a0\u2013 Gap analysis and remediation<\/li>\n<li><b>Mock Audits<\/b>\u00a0\u2013 Conducted by former notified body auditors<\/li>\n<li><b>MDSAP Preparation<\/b>\u00a0\u2013 Multi-country quality system compliance<\/li>\n<\/ul>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/quality-risk-audit.jpg\" alt=\"Compliance and quality assurance in medtech industry for accelerated medical device development and regulation.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Quality &#038; Compliance                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"specialized-expertise\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Specialized Expertise<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li><a href=\"https:\/\/mdxcro.com\/fr\/services\/precision-medicine-companion-diagnostics\/\"><b>Companion Diagnostics Strategy<\/b><\/a>\u00a0\u2013 Coordination with pharmaceutical partners<\/li>\n<li><b>Medical Device Design Consultancy<\/b>\u00a0\u2013 Regulatory integration in development<\/li>\n<li><b>Software as Medical Device (SaMD)<\/b>\u00a0\u2013 Classification and documentation<\/li>\n<li><b>MedTech Regulatory Consulting<\/b>\u00a0\u2013 Technology-specific approaches<\/li>\n<\/ul>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/technical-doc.jpg\" alt=\"High-level office worker managing large stacks of paperwork in a busy office environment, focused on data organization.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Specialized Expertise                        <\/button>\n                    <\/div>\n                <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"Case-Studies\" class=\"case-study-details\" style=\"\">\n    \n    \n    <div class=\"container\">\n                    <div class=\"headline\">Case Studies<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\" data-button-url=\"https:\/\/mdxcro.com\/fr\/case-studies\/mdr-transition-training-program-for-global-manufacturer\/\">\n                                                <div class=\"subtitle\">MDR Transition Training Program for Global Manufacturer<\/div>\n                                            <div class=\"list\">\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/challenge.svg\" alt=\"Challenge\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Challenge <\/span>\n                                        <p><span style=\"font-weight: 400;\">A leading medical device manufacturer with 30+ legacy products needed to prepare their regulatory affairs, quality, and R&amp;D teams for MDR transition within a compressed timeline.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/solution.svg\" alt=\"Solution\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Solution <\/span>\n                                        <p><span style=\"font-weight: 400;\">MDx developed a comprehensive 12-week hybrid training program including:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Executive briefings for leadership<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Technical workshops for subject matter experts<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Role-specific training modules for different departments<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Hands-on documentation workshops using the client&rsquo;s actual products<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Virtual coaching sessions for distributed teams<\/span><\/li>\n<\/ul>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/result.svg\" alt=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p><span style=\"font-weight: 400;\">65 employees across 3 countries successfully trained, resulting in a structured transition strategy. The company established an internal \u00ab\u00a0MDR Center of Excellence\u00a0\u00bb using our materials and train-the-trainer approach.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                <\/div>\n                    <\/div>\n                                    <div class=\"slider-item\" data-button-url=\"https:\/\/mdxcro.com\/fr\/case-studies\/notified-body-assessor-training-program\/\">\n                                                <div class=\"subtitle\">Notified Body Assessor Training Program<\/div>\n                                            <div class=\"list\">\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/challenge.svg\" alt=\"Challenge\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Challenge <\/span>\n                                        <p><span style=\"font-weight: 400;\">A major European Notified Body needed to quickly upskill their assessment team on IVDR requirements and performance evaluation processes to handle the influx of new submissions.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/solution.svg\" alt=\"Solution\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Solution <\/span>\n                                        <p><span style=\"font-weight: 400;\">MDx delivered a specialized training program for NB assessors that included:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">In-depth workshops on performance evaluation review<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Case-based learning with real-world technical documentation examples<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Assessment checklists and decision-making frameworks<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ongoing support and refresher sessions as interpretations evolved<\/span><\/li>\n<\/ul>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/result.svg\" alt=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p><span style=\"font-weight: 400;\">The Notified Body successfully trained 15 assessors with transformative efficiency gains. Our structured program reduced the assessor qualification journey from 18 months to just 6 months-a 66% reduction in onboarding time for new technical reviewers. The assessment team reported 40% faster review times after training completion, significantly increasing throughput capacity while maintaining rigorous compliance standards. Notified Body leadership reported substantial improvements in both operational efficiency and manufacturer satisfaction through more consistent, transparent, and timely evaluation.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                <\/div>\n                    <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                <a href=\"\/resources\/?category=case-studies\" class=\"button button--tertiary\">View Case Studies<\/a>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_b81df0d8bce12906fe78099020f51f5a\" class=\"testimonials\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg&#039;);\">\n        <div class=\"testimonials--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg\" \/>\n    <\/div>\n    <div class=\"container\">\n                    <div class=\"headline\">Client Testimonials<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0The ISO 13485 training provided by MDx transformed our quality management approach. Their former notified body experts shared practical insights that helped us achieve certification with zero nonconformities.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Quality Director                                                                 <br>\n                                European Medical Device Manufacturer                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0As regulatory consultants, MDx provided expertise we couldn&rsquo;t find elsewhere. When we learned they train Notified Body assessors themselves, we knew we&rsquo;d found the right partner. Their practical approach to our MDR submission cut months from our timeline.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Regulatory Affairs Director                                                                 <br>\n                                US-based Medical Device Startup                                        \n                            <\/p>\n                                            <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"FAQs\" class=\"faqs\" style=\"\">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Frequently Asked Questions<\/h2>\n                          <a class=\"button button--default\" href=\"https:\/\/mdxcro.com\/contact\/\" target=\"\">\n            Ask us a Question          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What qualifications do your trainers and consultants have?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Our team includes former notified body reviewers from BSI and T\u00dcV S\u00dcD, and industry experts with 15+ years of experience in regulatory affairs, quality management, and clinical evaluation. Many are active in industry working groups and standards committees, ensuring our guidance reflects current regulatory thinking. We&rsquo;re also selected by multiple European Notified Bodies to train their own assessors on IVDR and MDR requirements.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">How do your FDA 510(k) consulting services differ from other consultants?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Unlike generic regulatory consultants, our FDA submission experts have direct experience with successful 510(k), De Novo, and PMA submissions across multiple device categories. We provide end-to-end support from pre-submission strategy through response management, with a proven track record of first-time clearances. Our approach integrates regulatory strategy with quality compliance and clinical evidence development for comprehensive submission packages.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Do you offer certification for completed training programs?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Yes, participants receive certificates of completion for all formal training programs. For certain specialized courses, we offer competency-based certification that includes assessment of practical skills and knowledge application. These are valuable for demonstrating regulatory competence to notified bodies and during quality system audits.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Can you provide consulting services remotely?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Yes. While some projects benefit from on-site presence, we routinely provide highly effective consulting services remotely using secure document sharing platforms, video conferencing, and collaborative tools. This approach often reduces costs while maintaining quality and engagement, especially for document reviews and strategic consulting.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">How quickly can you develop custom training for our team?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">\u00a0For standard topics with customization, we can typically prepare and deliver training within 3-4 weeks. For highly specialized programs, 6-8 weeks allows for thorough needs assessment, material development, and review. For urgent needs, we offer accelerated options using our pre-developed modules with light customization.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Can you provide IVDR\/MDR transition strategies and gap assessments?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Absolutely. This is one of our core specialties. We offer both comprehensive training programs to build internal knowledge and consulting services to develop and execute transition strategies. Our approach includes document gap assessments, remediation plans, timeline development, and project management support tailored to your specific products and business needs.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                      <\/ul>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n  <script type=\"application\/ld+json\">\n    {\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What qualifications do your trainers and consultants have?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Our team includes former notified body reviewers from BSI and T\u00dcV S\u00dcD, and industry experts with 15+ years of experience in regulatory affairs, quality management, and clinical evaluation. Many are active in industry working groups and standards committees, ensuring our guidance reflects current regulatory thinking. We&rsquo;re also selected by multiple European Notified Bodies to train their own assessors on IVDR and MDR requirements.\"}},{\"@type\":\"Question\",\"name\":\"How do your FDA 510(k) consulting services differ from other consultants?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Unlike generic regulatory consultants, our FDA submission experts have direct experience with successful 510(k), De Novo, and PMA submissions across multiple device categories. We provide end-to-end support from pre-submission strategy through response management, with a proven track record of first-time clearances. Our approach integrates regulatory strategy with quality compliance and clinical evidence development for comprehensive submission packages.\"}},{\"@type\":\"Question\",\"name\":\"Do you offer certification for completed training programs?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes, participants receive certificates of completion for all formal training programs. For certain specialized courses, we offer competency-based certification that includes assessment of practical skills and knowledge application. These are valuable for demonstrating regulatory competence to notified bodies and during quality system audits.\"}},{\"@type\":\"Question\",\"name\":\"Can you provide consulting services remotely?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. While some projects benefit from on-site presence, we routinely provide highly effective consulting services remotely using secure document sharing platforms, video conferencing, and collaborative tools. This approach often reduces costs while maintaining quality and engagement, especially for document reviews and strategic consulting.\"}},{\"@type\":\"Question\",\"name\":\"How quickly can you develop custom training for our team?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"\u00a0For standard topics with customization, we can typically prepare and deliver training within 3-4 weeks. For highly specialized programs, 6-8 weeks allows for thorough needs assessment, material development, and review. For urgent needs, we offer accelerated options using our pre-developed modules with light customization.\"}},{\"@type\":\"Question\",\"name\":\"Can you provide IVDR\/MDR transition strategies and gap assessments?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Absolutely. This is one of our core specialties. We offer both comprehensive training programs to build internal knowledge and consulting services to develop and execute transition strategies. Our approach includes document gap assessments, remediation plans, timeline development, and project management support tailored to your specific products and business needs.\"}}]}  <\/script>\n\n\n\n<section id=\"popular-training\" class=\"text-image\" style=\"\">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Training &#038; Consulting Programs<\/h2><div class=\"description wysiwyg\"><p><b>Popular Training Courses<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>IVDR Compliance Training<\/b><span style=\"font-weight: 400\"> (3-day workshop)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>MDR Compliance Training<\/b><span style=\"font-weight: 400\"> (3-day workshop)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>ISO 13485 Training for Medical Device QMS<\/b><span style=\"font-weight: 400\"> (1-day workshop)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>ISO 14971 Risk Management Training<\/b><span style=\"font-weight: 400\"> (1-day workshop)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>IVD Design &amp; Development <\/b><span style=\"font-weight: 400\">(1-day workshop)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>FDA Regulatory Pathways &amp; Submissions<\/b><span style=\"font-weight: 400\"> (1-day workshop)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Notified Body Audit Preparation<\/b><span style=\"font-weight: 400\"> (1-day workshop)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Good Clinical Practice for Medical Device &amp; IVD Trials<\/b><span style=\"font-weight: 400\"> (1-day workshop)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>EUDAMED &amp; UDI Implementation<\/b><span style=\"font-weight: 400\"> (Half-day workshop)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Companion Diagnostics Regulatory Training<\/b><span style=\"font-weight: 400\"> (2-day workshop)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Medical Device Software Regulation<\/b><span style=\"font-weight: 400\"> (1-day workshop)<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/trainning-consultancy.jpg\" alt=\"Collaboration among diverse professionals in a conference room promoting innovative MedTech solutions for accelerated healthcare advancements.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_000dc6bb8d65cb5abb3ba68747ee46fd\" class=\"text-image text-image--reverse\" style=\"\">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><div class=\"description wysiwyg\"><p><b>Consulting Packages<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Regulatory Strategy Development<\/b><\/li>\n<li style=\"font-weight: 400\"><b>510(k) Submission Support<\/b><\/li>\n<li style=\"font-weight: 400\"><b>FDA Q-Submission Preparation<\/b><\/li>\n<li style=\"font-weight: 400\"><b>MDR\/IVDR Gap Assessment<\/b><\/li>\n<li style=\"font-weight: 400\"><b>Technical Documentation Review<\/b><\/li>\n<li style=\"font-weight: 400\"><b>QMS Implementation &amp; Remediation<\/b><\/li>\n<li style=\"font-weight: 400\"><b>Medical Device Design Consultancy<\/b><\/li>\n<li style=\"font-weight: 400\"><b>Regulatory Intelligence Reports<\/b><\/li>\n<li style=\"font-weight: 400\"><b>EU PRRC Services<\/b><\/li>\n<li style=\"font-weight: 400\"><b>And more\u2026<\/b><\/li>\n<\/ul>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDxCorporate_alta-calidad-25-scaled.jpg\" alt=\"Two people working in an office, one reviewing information on a laptop while the other offers assistance, at a table with documents and a cup. Innovative medtech collaboration for healthcare professionals, showcasing MDX Accelerating MedTech&#039;s commitment to advancing medical technology and supporting healthcare innovation.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section class=\"key-stats\"  style=\"\">\n    <div class=\"container\">\n          <div class=\"headline\">Success Metrics<\/div>\n    \n    <div class=\"main-wrapper\">\n              <div class=\"box-grid\">\n                                    <div class=\"box\">\n                                  <div class=\"value\">4.9\/5<\/div>\n                                                  <div class=\"legend\">average participant satisfaction rating<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">95%<\/div>\n                                                  <div class=\"legend\">of participants report direct application of learning to their work<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">3+<\/div>\n                                                  <div class=\"legend\">European Notified Bodies choose MDx to train their IVDR\/MDR assessors<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">100+<\/div>\n                                                  <div class=\"legend\">successful 510(k) and MDR\/IVDR submissions supported<\/div>\n                              <\/div>\n                              <\/div>\n      \n          <\/div>\n\n    <div class=\"data\">\n      \n          <\/div>\n  <\/div>\n<\/section>\n\n\n\n<section id=\"block_31f913ef4ad5815f3fc79a517c42f013\" class=\"call-to-action\" style=\"\">\n        <div class=\"call-to-action--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/mdx-cta-bg.png\" \/>\n    <\/div>\n    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"content\">\n                                    <h2 class=\"title\">Expert Training &amp; Consulting for Your Regulatory Success<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p><span style=\"font-weight: 400;\">Whether you need targeted regulatory guidance, comprehensive training, or strategic consulting, MDx delivers the expertise and practical support your team needs for successful market access.<\/span><\/p>\n<p><b>Expertise That Delivers. Knowledge That Transforms.<\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/contact\/?utm_source=training_consultancy\" class=\"button button--secondary\" target=\"\">\n                                Book a Consulting Session                            <\/a>\n                                                                                                <a href=\"https:\/\/mdxcro.com\/contact\/\" class=\"button button--tertiary\" target=\"\">\n                                Request a Training Course                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"Service\",\n  \"@id\": \"https:\/\/mdxcro.com\/services\/training-consultancy\/#service\",\n  \"name\": \"Training & Consultancy\",\n  \"serviceType\": \"Regulatory and clinical training, consulting, and advisory services for MedTech and IVD\",\n  \"url\": \"https:\/\/mdxcro.com\/services\/training-consultancy\/\",\n  \"description\": \"Professional training, workshops, and consulting support in regulatory affairs, clinical research, quality management systems, and technical documentation for MedTech and in vitro diagnostic (IVD) industries.\",\n  \"provider\": {\n    \"@type\": \"Organization\",\n    \"name\": \"MDx CRO\",\n    \"url\": \"https:\/\/mdxcro.com\"\n  },\n  \"areaServed\": [\"EU\",\"UK\",\"US\"],\n  \"audience\": {\n    \"@type\": \"Audience\",\n    \"audienceType\": \"Regulatory professionals, quality managers, clinical teams, and MedTech\/IVD stakeholders\"\n  },\n  \"serviceOutput\": \"Training materials, consultancy deliverables, workshops, and tailored advisory outcomes\",\n  \"hasOfferCatalog\": {\n    \"@type\": \"OfferCatalog\",\n    \"name\": \"Training & Consultancy Services\",\n    \"itemListElement\": [\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Regulatory affairs training (IVDR, MDR, FDA)\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Clinical research and monitoring workshops\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Quality management systems (ISO 13485) consultancy\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Technical documentation & submission support consulting\"\n        }\n      }\n    ]\n  },\n  \"sameAs\": [\n    \"https:\/\/www.linkedin.com\/company\/medtech-ivd-cro\/\"\n  ]\n}\n<\/script>\n\n\n\n<p><\/p>\n","protected":false},"featured_media":0,"parent":0,"menu_order":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-676","service","type-service","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Regulatory Training &amp; Consulting for Medical Devices &amp; IVD<\/title>\n<meta name=\"description\" content=\"Former BSI &amp; T\u00dcV S\u00dcD experts, trusted by European NB to train their own MDR\/IVDR assessors. Workshops, on-demand consulting, and gap assessments for MedTech teams. Book a session.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mdxcro.com\/fr\/services\/training-consultancy\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory Training &amp; Consulting for Medical Devices &amp; IVD\" \/>\n<meta property=\"og:description\" content=\"Former BSI &amp; T\u00dcV S\u00dcD experts, trusted by European NB to train their own MDR\/IVDR assessors. Workshops, on-demand consulting, and gap assessments for MedTech teams. 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