Petra De Geest

Medical Affairs Manager – Medical Writing & Safety Expert

12 years of experience in the medical device field. Expert in clinical evidence and medical writing for Class I to Class III devices, including MDSW and AI-driven MDSW, as well as safety management in clinical investigations.

2 articles

Regulatory Affairs2025年9月4日 2 分钟

PMCF: How QbD Group Helps You Master MDR Compliance from Plan to Report

Discover how QbD supports MDR compliance with strategic PMCF planning, execution, and documentation, from plan to report.

Clinical2025年3月5日 10 分钟

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) under the MDR: Ensuring safety and performance

With the introduction of the Medical Device Regulation (MDR), the requirements for placing medical devices on the market have significantly increased. Additional manufacturers’ obligations concerning post-market surveillance (PMS), including post-market clinical follow-up (PMCF), have gained importance.

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