Clinical Evaluation for Medical Devices

Clinical Evaluation for Medical Devices – based on MEDDEV 2.7/1 rev 4 and MDR requirements

This course provides practical insights into performing Clinical Evaluations following MEDDEV 2.7/1 rev 4 and MDR. Through group discussions, case studies, and examples, you’ll learn how to plan, write, and tailor clinical evaluations for your device.

What You’ll Learn:

· The stages of clinical evaluation: scoping, data identification, appraisal, and analysis

· Practical tips for systematic literature reviews and State-of-the-Art (SoTA) overviews

· Assessing clinical data validity and risk of bias

· Differences between MDD, MEDDEV, and MDR

· Post Market Clinical Follow-up (PMCF) and when it may be waived

· Useful tools and templates for clinical evaluation reports

Who Should Attend:

Regulatory, quality, risk management, and clinical professionals in medical devices who write, review, or audit clinical evaluation reports.

Prerequisites:

Basic knowledge of scientific database searching

Experience in regulatory report writing

6–12 months’ experience in the regulated medical device or pharmaceutical industry

Instructor:

Maria de Matos, Clinical Development Consultant at GBA Key2Compliance with 10+ years in Life Science, PhD in Pharmaceutical Technologies, and expertise in clinical evaluations and post-market surveillance.