A review of changes made to the standard published earlier this year.
Is your risk management process rock solid?
A look at some common mistakes medical device companies make when approaching risk.
There’s a greater emphasis on being able to demonstrate competence in performing required activities.
Device manufacturers must do more to integrate supplier and clinical perspectives during the product design process.
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.