Considerations for designing and implementing successful PMCF surveys
£0.00
Ensure the success of your Post-Market Clinical Follow-up surveys with proven strategies for design and implementation
English
Since the implementation of the European Medical Device Regulation (MDR), device manufacturers are increasingly being asked to be more proactive in assessing the safety and performance of their products, backing this up with clinical data and post-market monitoring. The data collected are then used to update risk management and the clinical evaluation of each device. There are many ways to collect these post-market data, including randomised clinical trials, registries, literature reviews, and surveys. This article by Marcus Torr focuses on post-market clinical follow-up (PMCF) surveys as a compliant approach for post-market data collection to complete a successful Notified Body audit and MDR certification.
Specification: 13 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the May 2022 issue of the Journal of Medical Device Regulation.
