Medtech companies should be taking a broad approach to assessing risk.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.
A review of the articles you found most interesting this year.
A look into the importance of high-quality software in the medical device industry.
When entering this emerging market, the benefits may outweigh any risks.
Risk Management is the single most important topic impacting the medical device industry today.
CDRH’s Carl Fischer shares the agency’s approach to organizing and managing complaints.
A review of how to incorporate complaint handling and risk management into the postmarket surveillance process.
Comply all the time, not just when FDA announces an inspection.
A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.