{"id":677,"date":"2025-07-30T07:21:40","date_gmt":"2025-07-30T07:21:40","guid":{"rendered":"http:\/\/mdx.local\/?post_type=service&#038;p=677"},"modified":"2026-04-16T08:20:45","modified_gmt":"2026-04-16T08:20:45","slug":"medtech-clinical-solutions","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/fr\/services\/medtech-clinical-solutions\/","title":{"rendered":"MedTech Clinical Solutions"},"content":{"rendered":"\n<section id=\"block_309d6374ed5f0e82ae32a7190e489d51\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/sectors-MDx-CRO-2.webp\" fetchpriority=\"high\" class=\"no-lazy\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">MedTech Clinical Solutions<\/h1>\n            \n                            <div class=\"description\"><p>Accelerate Your MedTech Trials, From Design to Global Submission<br \/>\n<span style=\"font-weight: 400;\">MDx delivers expert-led, ISO 14155\/20916-compliant <a href=\"https:\/\/mdxcro.com\/fr\/services\/clinical-research\/\">clinical research<\/a> and investigations for IVDs and medical devices\u2014supporting MDR, IVDR, FDA IDE, and global approvals<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/contact\/?utm_source=medtech_clinical_solutions\" class=\"button button--default\" target=\"_self\">\n                            Book a Discovery Call                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/contact\/?utm_source=services&#038;utm_content=MedTech_Clinical_Solutions\" class=\"button button--secondary\" target=\"_self\">\n                            Plan your Study with MDx                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_dda4a518b184e54ada72d71cb454384c\" class=\"text-image\" style=\"margin-top: var(--wp--preset--spacing--xxlarge); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Your MedTech <span class=\"blue-highlight\"> CRO <\/span> Partner<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">At MDx, we offer <\/span><b>end-to-end clinical solutions<\/b><span style=\"font-weight: 400\"> for both IVD and medical device manufacturers. From <\/span><b>protocol design and feasibility<\/b><span style=\"font-weight: 400\"> to <\/span><b>regulatory submissions and monitoring<\/b><span style=\"font-weight: 400\">, we ensure clinical success\u2014faster, smarter, and globally compliant.<\/span><\/p>\n<p><b>Trusted by global sponsors<\/b><span style=\"font-weight: 400\"> including top 10 IVD and MedTech manufacturers.<\/span><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Untitled-106.jpg\" alt=\"Thorough checklist and documents process for Medical Device companies, focusing on compliance, quality assurance, and accelerating MedTech innovation.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_b37f2dcbcdfb27f983e23a3c3e0fa8f3\" class=\"text-image text-image--reverse\" style=\"margin-top: var(--wp--preset--spacing--xxlarge); margin-bottom: var(--wp--preset--spacing--xxlarge); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Why Sponsors Choose <span class=\"blue-highlight\"> MDx <\/span><\/h2><div class=\"description wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">ISO 14155 \/ ISO 20916 Clinical Operations<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Full-service EU MDR, IVDR, and FDA IDE support<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Delegated sponsor &amp; EU Legal Representative<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">In-house monitoring, biostats, data management<\/span><\/li>\n<li style=\"font-weight: 400\">eCRF, eTMF, QMS &amp; audit readiness<\/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-5-scaled.jpg\" alt=\"Innovative MDX medical technology at work with a smiling woman healthcare professional during an online meeting. Focus on advancing MedTech solutions and digital health innovation.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_b9da8587bd8c31e4ba46a01fdda54407\" class=\"content-columns content-columns--four-columns \" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Our Clinical Services<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Strategy &#038; Planning<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Clinical Strategy<\/span><\/li>\n<li><span style=\"font-weight: 400\">Study Feasibility &amp; Site Selection<\/span><\/li>\n<li><span style=\"font-weight: 400\">Protocol Development (CIP \/ CPSP)<\/span><\/li>\n<li><span style=\"font-weight: 400\">Risk Management Planning<\/span><\/li>\n<li><span style=\"font-weight: 400\">Clinical Strategy<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-black\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Execution &#038; Oversight<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">eCRF Design &amp; Data Collection<\/span><\/li>\n<li><span style=\"font-weight: 400\">eTMF Management<\/span><\/li>\n<li><span style=\"font-weight: 400\">Central, On-site &amp; Risk-Based Monitoring<\/span><\/li>\n<li><span style=\"font-weight: 400\">Biostatistics &amp; Data Management<\/span><\/li>\n<li><span style=\"font-weight: 400\">Progress Reports &amp; End of Study Reporting (CIR, CPSR)<\/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\">Regulatory &#038; Compliance<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">MDR, IVDR, FDA<\/span><\/li>\n<li><span style=\"font-weight: 400\">Ethics &amp; Competent Authority Submissions (EU, UK, US)<\/span><\/li>\n<li><span style=\"font-weight: 400\">EU \/UK Legal Representation<\/span><\/li>\n<li><span style=\"font-weight: 400\">EUDAMED Registration<\/span><\/li>\n<li><span style=\"font-weight: 400\">CAPA &amp; Audit Readiness<\/span><\/li>\n<li><span style=\"font-weight: 400\">GCP, ISO 14155\/20916 Compliance<\/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\">Usability &#038; Human Factors<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Formative and Summative Studies<\/span><\/li>\n<li><span style=\"font-weight: 400\">IEC 62366 &amp; FDA Human Factors Compliance<\/span><\/li>\n<li><span style=\"font-weight: 400\">Usability &amp; Human Factors<\/span><\/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\">CRO Comparison Table<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">CRO Services<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\">Clinical Project Management<\/td><\/tr><tr><td class=\"feature-cell\">Protocol Development<\/td><\/tr><tr><td class=\"feature-cell\">Regulatory Support (MDR &amp; IVDR)<\/td><\/tr><tr><td class=\"feature-cell\">Study Audits (ISO 14155 \/ ISO 20916)<\/td><\/tr><tr><td class=\"feature-cell\">EU\/UK Legal Representative<\/td><\/tr><tr><td class=\"feature-cell\">Biostatistics &amp; Data Management<\/td><\/tr><tr><td class=\"feature-cell\">eTMF &amp; eCRF Tools<\/td><\/tr><tr><td class=\"feature-cell\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Clinical Compliance<\/mark><\/strong><\/td><\/tr><tr><td class=\"feature-cell\">SOPs for GCP, ISO 14155 &amp; ISO 20916<\/td><\/tr><tr><td class=\"feature-cell\">Multilingual Clinical Team<\/td><\/tr><tr><td class=\"feature-cell\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Expertise &amp; Stakeholder Engagement<\/mark><\/strong><\/td><\/tr><tr><td class=\"feature-cell\">MDR, IVDR, FDA, CA Strategy<\/td><\/tr><tr><td class=\"feature-cell\">Complex High-Risk Device Experience<\/td><\/tr><tr><td class=\"feature-cell\">Software as a Medical Device (SaMD) Expertise<\/td><\/tr><tr><td class=\"feature-cell\">EU Engagement (EMA, MDCG, Notified Bodies)<\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">MDx<\/th><th class=\"column\">Other CROs<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Yes<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7064 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-blue.svg\" alt=\"\">Yes<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">In-house expertise<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Often outsourced<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Specialized support<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Generalist support<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Conducted by MDx experts<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Rarely offered<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Included<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Limited availability<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Fully in-house<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Often outsourced<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Certified systems<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Limited<\/td><\/tr><tr><td class=\"cell highlight\"><\/td><td class=\"cell\"><\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Robust &amp; harmonized<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Partial<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">14+ Languages<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Limited coverage<\/td><\/tr><tr><td class=\"cell highlight\"><\/td><td class=\"cell\"><\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Proven track record<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Partial<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Extensive<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Limited<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Specialized<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Rarely supported<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Active participation<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">No direct access<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n\n\n<section id=\"block_c954aa3a0e5a05e641f8e14b06ad100d\" class=\"content-columns content-columns--three-columns \" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Therapeutic Areas &#038; Technologies<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Therapeutic <span class=\"blue-highlight\"> Expertise <\/span><\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Oncology<\/span><\/li>\n<li><span style=\"font-weight: 400\">Cardiovascular<\/span><\/li>\n<li><span style=\"font-weight: 400\">Orthopaedics &amp; Dental<\/span><\/li>\n<li><span style=\"font-weight: 400\">Infectious Diseases<\/span><\/li>\n<li><span style=\"font-weight: 400\">Woundcare<\/span><\/li>\n<li><span style=\"font-weight: 400\">Reproductive Health<\/span><\/li>\n<li><span style=\"font-weight: 400\">Neurology &amp; Mental Health<\/span><\/li>\n<li><span style=\"font-weight: 400\">Critical Care<\/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\">Technologies<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">SaMD &amp; Digital Health<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Implantable Devices<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Imaging Technologies<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Combination Products<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">In Vitro Diagnostics (IVDs): PCR, NGS, IHC, immunoassays, etc<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n                    <div class=\"button-wrapper\">\n                                    <a href=\"\/expertise\/therapeutic-areas\" class=\"button button--default\" target=\"_self\">\n                        Explore All Therapeutic Areas                     <\/a>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_762f01d649179adadd71f3ac3afcd63f\" class=\"text-image\" style=\"margin-top: var(--wp--preset--spacing--xxlarge); margin-bottom: var(--wp--preset--spacing--xxlarge); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Our Clinical Impact<\/h2><div class=\"description wysiwyg\"><ul>\n<li><b>100% success rate<\/b><span style=\"font-weight: 400\"> in IVDR &amp; MDR study submissions<\/span><\/li>\n<li><b>30+ complex trials<\/b><span style=\"font-weight: 400\"> managed for Class II\/III and high-risk IVDs<\/span><\/li>\n<li><b>60+<\/b><span style=\"font-weight: 400\"> IVD performance study submissions across Europe<\/span><\/li>\n<li><b>SaMD <\/b><span style=\"font-weight: 400\">and digital therapeutics fully managed through to submission<\/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\/07\/Untitled-12.jpg\" alt=\"Advanced healthcare professionals monitoring patient vitals with medical devices in a hospital setting, emphasizing MedTech innovation and clinical excellence.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_637159211f1a591de270ebac650d8b97\" class=\"charts\" style=\"\">\n    <div class=\"container\">\n\t\t  <h2 class=\"headline\">Project Types We Manage<\/h2>\n\t\n\t\t  \t\t<h3 class=\"subtitle\"> IVD  Performance Studies<\/h3>\n\t  \n\t  <div class=\"grid\">\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3, #8eebe1, #79c4bd\"\n\t\t\tdata-values=\"35.8, 25.5, 21.3, 9.2, 8.2\"\n\t\t\tdata-labels=\"Infection\/ Immunity, CDx, Genetic Tests, Physiological Markers, Others\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3\"\n\t\t\tdata-values=\"85, 11, 4\"\n\t\t\tdata-labels=\"Class C, Class B, Class D\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t  <\/div>\n\t\t  \t\t<h3 class=\"subtitle\">Medical Device Clinical Investigations<\/h3>\n\t  \n\t  <div class=\"grid\">\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3, #8eebe1\"\n\t\t\tdata-values=\"62.5, 19.3, 8, 10.2\"\n\t\t\tdata-labels=\"Implantable, General, Active Implantable, Active\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3\"\n\t\t\tdata-values=\"29.6, 29.6, 40.8\"\n\t\t\tdata-labels=\"Class III, Class IIb, Class IIa\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t  <\/div>\n\t  <\/div>\n<\/section>\n\n\n<section id=\"block_b1af5478cf4dd3d1deb2b2725a5ce0a8\" 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\">Trusted by Global Sponsors<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0MDx delivered exceptional clinical execution for our MDR Class III implantable. Their ISO 14155 expertise, monitoring, and submission support helped us gain approval faster than expected.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                \u2014 VP, Clinical Affairs, Top 25 Global Device Manufacturer                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0The team\u2019s ability to translate technical needs into compliant documentation was invaluable.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                \u2014 Director, Regulatory Affairs, SME MedTech Firm                                        \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=\"block_228315a00ec6dd71e31497f3f00c9c9a\" 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--quaternary\" 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\">Do you manage both IVD and Medical Device studies?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Yes \u2014 across MDR, IVDR, FDA IDE, IRB, and more.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Can MDx act as Legal Representative in the EU?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Yes \u2014 under MDR (Art. 62.2) and IVDR (Art. 58.4), we can act as legal rep or delegated sponsor. We also provide UK RP services.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Do you support software as a medical device (SaMD)?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">\u00a0Yes. We support digital therapeutics, diagnostics, and SaMD studies with IEC 62366-aligned usability testing and FDA Human Factors guidance.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What\u2019s the difference between a clinical trial, investigation, and performance study?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><i><span style=\"font-weight: 400\">Clinical trial<\/span><\/i><span style=\"font-weight: 400\"> = general term<\/span><span style=\"font-weight: 400\"><br \/>\n<\/span><i><span style=\"font-weight: 400\">Clinical investigation<\/span><\/i><span style=\"font-weight: 400\"> = for medical devices<\/span><span style=\"font-weight: 400\"><br \/>\n<\/span><i><span style=\"font-weight: 400\">Performance study<\/span><\/i><span style=\"font-weight: 400\"> = for IVDs<br \/>\n<\/span><span style=\"font-weight: 400\">We support all \u2014 from feasibility to full submissions.<\/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\":\"Do you manage both IVD and Medical Device studies?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes \u2014 across MDR, IVDR, FDA IDE, IRB, and more.\"}},{\"@type\":\"Question\",\"name\":\"Can MDx act as Legal Representative in the EU?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes \u2014 under MDR (Art. 62.2) and IVDR (Art. 58.4), we can act as legal rep or delegated sponsor. 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Our Regulatory Precision.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Whether you&rsquo;re launching a complex IVD study or preparing for global submissions, MDx is your full-service CRO for high-impact clinical outcomes.<\/span><\/p>\n<p><strong>\u00a0Your Device. Our Expertise. Global Impact.<\/strong><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/contact\/?utm_source=medtech_clinical_solutions\" class=\"button button--tertiary\" target=\"\">\n                                Book a Discovery Call                            <\/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\/medtech-clinical-solutions\/#service\",\n  \"name\": \"MedTech Clinical Solutions\",\n  \"serviceType\": \"End-to-end clinical research solutions for medical devices and IVD clinical investigations\",\n  \"url\": 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