Live! #90 – PMCF Surveys That Survive Scrutiny

Live! #90 – PMCF Surveys That Survive Scrutiny

From Making MedTech Happen with RQM+ by RQM+

November 3, 2025 · 1h 12m

About this episode

This episode discusses how to design PMCF surveys that meet regulatory scrutiny and improve data quality.

This panel was recorded October 2, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠⁠ RQMplus.com ⁠⁠ . PMCF surveys can strengthen your CER and PSUR or create rework. In this 60-minute panel with live audience Q&A, RQM+ leaders from regulatory, clinical, and scientific writing share what MDR reviewers look for and how to design surveys that generate decision-grade evidence. The session is intended for regulatory affairs, post-market surveillance, clinical evidence, and medical writing leaders at MedTech manufacturers. Listen to learn how to: Define clear objectives, endpoints, and target population so the survey maps to your PMCF plan and CER. Improve response rates without bias and capture higher-quality data, including adverse events and usability feedback. Learn how to position your physician level survey as a chart review. Document methods, rationales, and traceability so notified bodies can follow the logic. Avoid the top reasons reviewers push back on PMCF surveys and how to correct them. Walk away with a practical checklist to…

People in this episode

Host: RQM+

Topics covered

  • PMCF surveys
  • regulatory affairs
  • clinical evidence
  • post-market surveillance
  • medical writing

Keywords

  • PMCF
  • surveys
  • regulatory
  • clinical evidence
  • data quality
  • adverse events
  • usability feedback

Mentioned in this episode

Organizations: MDR, CER, PSUR, MedTech

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