This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.
Procedures for design validation must address risk analysis where appropriate.
With the heightened supplier scrutiny, it’s time to reevaluate your supplier quality program.
How much do you know about this standard? Review the results.
Is your risk management process fully operational right now?
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.