Program Overview
This expert-led program delivers a deep, practical understanding of clinical evaluation requirements for medical devices under EU MDR, IVDR, MEDDEV 2.7/1 Rev. 4, and FDA frameworks. Participants will explore the lifecycle approach to clinical evaluation, critical appraisal of data, equivalence challenges, and integration with post-market surveillance. Through real-world case examples, interactive exercises, and mock Notified Body simulations, professionals will gain actionable skills to draft and maintain Clinical Evaluation Reports (CERs), address audit challenges, and accelerate regulatory approvals. The session balances conceptual clarity with hands-on problem-solving, ensuring immediate applicability in corporate environments.
Features
- Interpret and apply global regulatory requirements for clinical evaluation (EU MDR, IVDR, US FDA, etc.).
- Draft and critically assess Clinical Evaluation Reports in line with MEDDEV 2.7/1 Rev. 4.
- Differentiate between literature-based evidence, PMCF data, and clinical investigations.
- Design robust clinical evaluation strategies to address Notified Body expectations and audit challenges.
Target audiences
- Regulatory Affairs Managers & Specialists
- Clinical Affairs Professionals
- Quality & Compliance Teams
- R&D & Product Development Teams
- Project Managers in MedTech
Curriculum
- 5 Sections
- 23 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- Foundations of Clinical Evaluation4
- Regulatory Guidance & Industry Expectations4
- Clinical Data Sources & Evaluation Pathways5
- Building & Maintaining a Robust CER6
- 4.1Structure of a Clinical Evaluation Report
- 4.2Critical appraisal of literature (exercise: scoring study quality)
- 4.3Gap analysis workshop: Identify missing evidence for a sample device
- 4.4Mock Notified Body Q&A on a CER submission
- 4.5Iterative Updates, Living CER, Clinical Evaluation Plan (CEP)
- 4.6Summary of Safety and Clinical Performance (SSCP)
- Forward-Looking Strategies & Wrap-Up4
Instructor
