The first critical step in being able to feel confident about your clinical evaluation reports (CERs) is to ensure you know exactly what they entail.
The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.
Take a proactive approach to achieving regulatory compliance.
A review of how to incorporate complaint handling and risk management into the postmarket surveillance process.
A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.