Petra De Geest

Business Unit Manager Medical Affairs

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.

8 articles

Regulatory Affairs29 abr 2026 3 min

The Hidden Operational Hurdles of EU Market Entry

CE marking isn't just clinical and regulatory. Discover the hidden operational hurdles that delay EU market entry.

Regulatory Affairs29 abr 2026 3 min

Why Clinical Strategy Is the Real Bottleneck for EU Market Access

Discover why clinical strategy, not data, is the real bottleneck for EU MDR market access and how to align regulatory and clinical decisions.

Regulatory Affairs29 abr 2026 3 min

Clinical Evidence Under EU MDR: What Non-EU Manufacturers Get Wrong

Discover what non-EU manufacturers get wrong about clinical evidence under the EU MDR, from CER requirements to PMCF and data reuse.

Regulatory Affairs29 abr 2026 3 min

The EU Notified Body Process: What Every Non-EU Manufacturer Should Know

Understand the EU Notified Body process for medical devices, from selection to review timelines and common delays under the MDR.

Regulatory Affairs29 abr 2026 2 min

Why FDA or NMPA Approval Does Not Mean You're Ready for Europe

FDA or NMPA approval doesn't guarantee EU readiness. Discover the key gaps MedTech companies face when transitioning to EU MDR.

Regulatory Affairs15 abr 2026 1 min

Home Market Approval ≠ EU Readiness

FDA or NMPA approval doesn't mean EU readiness. Learn why home market success often leads to delays under EU MDR, and how to avoid them.

Regulatory Affairs4 sept 2025 2 min

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.

Clinical5 mar 2025 10 min

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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