Expert-Led Training & Regulatory Consulting for MedTech Success
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.
Transform Regulatory Complexity Into Strategic Advantage
In today’s evolving medical device and IVD regulatory landscape, having access to specialized knowledge is your competitive edge. MDx CRO delivers targeted training and expert consulting services that build internal capabilities, strengthen compliance strategies, and drive successful regulatory outcomes.
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.
Trusted by Notified Bodies: 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.
Our Training Portfolio
Regulatory Frameworks & Standards Training
EU Regulatory Training
FDA & Global Pathways
Quality & Standards Mastery
| Format |
|---|
| Onsite Workshops |
| Virtual Training |
| Hybrid Programs |
| Train-the-Trainer |
| Executive Briefings |
| Custom Consulting |
| Description | Best For |
|---|---|
| Hands-on, interactive sessions at your facility with practical exercises and implementation focus | Cross-functional teams requiring immersive learning |
| Live, instructor-led sessions with interactive components and digital materials | Distributed teams or flexible scheduling needs |
| Combination of self-paced learning and live sessions | Comprehensive programs requiring different learning modes |
| Intensive programs to develop internal training capabilities | Organizations building sustainable internal expertise |
| Concise, strategic sessions for leadership | C-suite and senior management decision-making |
| Targeted expertise to solve specific challenges | Addressing immediate regulatory or quality gaps |
Our Training Methodology
MDx delivers a comprehensive learning experience that transforms theory into practical implementation:
Understanding your team’s knowledge baseline and specific challenges
Tailoring materials to your products, processes, and regulatory goals
Case studies, workshops, and problem-solving exercises
Verification of understanding and competence
Post-training assistance with applying concepts
Follow-up and refresher options for sustained skills development
Consulting Approaches
Strategic Support for Every Regulatory Challenge
On-Demand Expert Access
Technical Documentation Review
Strategic Planning & Implementation
Fractional Regulatory Support
FDA Submission Support
- 510(k) Submission Consulting – Pathway determination, substantial equivalence
- Q-submission Strategy – Pre-submission meeting preparation and execution
- Response Management – Additional information requests and deficiency letters
- FDA Regulatory Consulting – Product classification, regulatory strategy
EU Regulatory Strategy
- MDR/IVDR Gap Assessment – Technical documentation and process evaluation
- CE Marking Strategy – Conformity assessment planning
- Classification Consulting – Product qualification and rule interpretation
- Notified Body Selection – Matching your needs with optimal NB expertise
Quality & Compliance
- Quality System Implementation – ISO 13485 and FDA QSR
- Medical Device Compliance Consulting – Gap analysis and remediation
- Mock Audits – Conducted by former notified body auditors
- MDSAP Preparation – Multi-country quality system compliance
Specialized Expertise
- Companion Diagnostics Strategy – Coordination with pharmaceutical partners
- Medical Device Design Consultancy – Regulatory integration in development
- Software as Medical Device (SaMD) – Classification and documentation
- MedTech Regulatory Consulting – Technology-specific approaches
A leading medical device manufacturer with 30+ legacy products needed to prepare their regulatory affairs, quality, and R&D teams for MDR transition within a compressed timeline.
MDx developed a comprehensive 12-week hybrid training program including:
- Executive briefings for leadership
- Technical workshops for subject matter experts
- Role-specific training modules for different departments
- Hands-on documentation workshops using the client’s actual products
- Virtual coaching sessions for distributed teams
65 employees across 3 countries successfully trained, resulting in a structured transition strategy. The company established an internal “MDR Center of Excellence” using our materials and train-the-trainer approach.
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.
MDx delivered a specialized training program for NB assessors that included:
- In-depth workshops on performance evaluation review
- Case-based learning with real-world technical documentation examples
- Assessment checklists and decision-making frameworks
- Ongoing support and refresher sessions as interpretations evolved
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.
Frequently Asked Questions
Ask us a Question- What qualifications do your trainers and consultants have?
Our team includes former notified body reviewers from BSI and TÜV SÜD, 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’re also selected by multiple European Notified Bodies to train their own assessors on IVDR and MDR requirements.
- How do your FDA 510(k) consulting services differ from other consultants?
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.
- Do you offer certification for completed training programs?
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.
- Can you provide consulting services remotely?
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.
- How quickly can you develop custom training for our team?
For 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.
- Can you provide IVDR/MDR transition strategies and gap assessments?
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.
Training & Consulting Programs
Popular Training Courses
- IVDR Compliance Training (3-day workshop)
- MDR Compliance Training (3-day workshop)
- ISO 13485 Training for Medical Device QMS (1-day workshop)
- ISO 14971 Risk Management Training (1-day workshop)
- IVD Design & Development (1-day workshop)
- FDA Regulatory Pathways & Submissions (1-day workshop)
- Notified Body Audit Preparation (1-day workshop)
- Good Clinical Practice for Medical Device & IVD Trials (1-day workshop)
- EUDAMED & UDI Implementation (Half-day workshop)
- Companion Diagnostics Regulatory Training (2-day workshop)
- Medical Device Software Regulation (1-day workshop)
Consulting Packages
- Regulatory Strategy Development
- 510(k) Submission Support
- FDA Q-Submission Preparation
- MDR/IVDR Gap Assessment
- Technical Documentation Review
- QMS Implementation & Remediation
- Medical Device Design Consultancy
- Regulatory Intelligence Reports
- EU PRRC Services
- And more…
Expert Training & Consulting for Your Regulatory Success
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.
Expertise That Delivers. Knowledge That Transforms.
