New Guidance Templates for the Post-Market Clinical Follow-Up (PMCF) Plan and PMCF Evaluation Report
Author: Suzanne Broussard The newest guidance documents for post-market clinical follow-up (PMCF) requirements have just been released by the Medical Device Coordination Group (MDCG). The two documents provide guidance templates for the PMCF plan and the […]
[FREE WEBINAR] Live Q&A Follow-Up: How to Assess Your CER for MDR Readiness, Part 1
Click here to watch the recording. We had such a large turnout at our previous webinar, How to Assess Your CER for MDR Readiness, Part 1, and left with some […]
The Summary of Safety and Clinical Performance (SSCP) is a Required Part of Medical Device Regulation (MDR) 2017/745: Is Your Organization Ready?
Author: Suzanne Broussard The Summary of Safety and Clinical Performance (SSCP) plays an important part of the very strong post-market follow-up required in MDR 2017/745 for implantable and class III medical devices. The SSCP is intended to provide healthcare workers and […]
