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.

3 articles

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.

Usamos cookies para mejorar tu experiencia

Usamos cookies esenciales para el funcionamiento del sitio y cookies de análisis opcionales para mejorar nuestros servicios. Consulta nuestra Política de privacidad y Política de cookies.