Aaron Joseph

I’ve helped many medical device development teams with formal risk assessment and I’m often asked, “Why do we need to do this?” This question doesn’t mean they don’t care about product safety. They just don’t see the value in the formal process and documentation. Compiling a documented risk assessment is difficult and time consuming. It

Compiling a Hazards and Harms List (HHL) at the beginning of medical device development is a simple technique to improve all risk management activities for that product (or family of products). Have you ever been in an audit trying to explain to the auditor why the severity of a particular harm is rated differently in