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RQM+ Live! #90 – PMCF Surveys That Survive Scrutiny: What Reviewers Want and How to Deliver

RQM+

01:11:42

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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. 

Join 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 pressure test your next PMCF survey and reduce review risk. 

Who should attend: 

  • Regulatory affairs leaders and PMS managers. 
  • Clinical evidence and clinical operations leads. 
  • Scientific and medical writing leaders, including CER and PSUR authors. 
  • Quality leaders responsible for post market surveillance programs. 

Panelists and moderator: 

  • Torrie DeGennaro – Vice President, Scientific & Medical Writing 
  • Bethany Chung, Ph.D., RAC – Director, Technical Solutions & Innovation 
  • Garrett Jeffries, Ph.D. – Principal 
  • Jon Gimbel, Ph.D. – Vice President, Regulatory Affairs 

Certificate of attendance available upon request for live attendees.

Speakers

Torrie DeGennaro

Torrie DeGennaro

Vice President, Scientific & Medical Writing

Garrett Jeffries

Garrett Jeffries

Principal

Bethany Chung, PhD, RAC

Bethany Chung, PhD, RAC

Director of Technical Solutions & Innovation, RQM+

Jon Gimbel, Ph.D.

Jon Gimbel, Ph.D.

Vice President, Regulatory Affairs

RQM+ Live! #90 – PMCF Surveys That Survive Scrutiny: What Reviewers Want and How to Deliver

01:11:42

Watch