Author: genia229532791
SARACA’s post market clinical follow-up survey tool FastPMCF reduces lead time up to 40%
The tool potentially reduces the overall lead time for conducting post market clinical follow-up (PMCF) surveys to approximately 40 percent compared to conventional methods. To keep the devices on the market, manufacturers must continuously and proactively collect end user feedback to support and document clinical claims.
A PMCF survey can fulfil this requirement and be a potentially good approach for collecting real world evidence to ensure continued safety and performance of live saving medical devices. However, manufacturers face multiple challenges for conducting these surveys which hinders the timely submission of regulatory documents to the notified bodies.
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