Clinical Evaluation & Investigation Training Course

Module 1: Introduction – Overview of the course objectives
Importance of regulatory knowledge in the medical device industry and clinical needs.
Overview of the Medical Device Regulation (MDR) and other key standards with Clinical data.

Module 2: Requirements, Data Requirements and Preparation
Understanding regulatory requirements for medical devices.
Essential data and documentation needed for Clinical evidence.
Preparation for regulatory submissions and approvals.
Key stakeholders in the process.

Module 3: Safety/Performance, Report writing, The new MDR and notified body expectations
Key safety and performance requirements under the MDR.
Effective report writing for regulatory submissions.
Changes and updates under the EU MDR.
Expectations from notified bodies in terms of compliance and documentation.
How to address safety and performance challenges.

Module 4: Post Market, Risk Management and Maintenance
Post-market surveillance strategies and requirements.
Risk management processes under the MDR.
Ensuring continuous device performance post-market.
Maintaining compliance through the product lifecycle.

Module 5: Application of MED DEV 2.7.1 and Chapter VI of the MDR via Case Studies
Detailed exploration of MED DEV 2.7.1 and its role in the regulatory process.
Understanding Chapter VI of the MDR related to clinical evaluations.
Application of these concepts through real-world case studies.

Module 6: End of course assessment
A comprehensive assessment to evaluate understanding of the course material.
Focus on real-world application of regulatory knowledge.
Discussion of results and feedback for continuous improvement.

This outline can be adjusted to fit the specific needs of your course, including more detail or additional modules if needed.