Regulatory Affairs2026年4月15日 1 分钟
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.
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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.
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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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