Wednesday, 8 February 2017

Medical Device Risk – ISO 14971 Gets It Right

William Storage has written an interesting article on risk assessment. Here’s a quote from the thought provoking article: “Obvious as those may seem, defining risk in terms of hazards is surprisingly uncommon; leaving severity out of its definition is far too common; and many who include it define risk as an arithmetic product of probability and severity, which often results in nonsense.”

14971 identifies a proper hierarchy of risk-control options that provide guidance from conceptual design through release of medical devices. This is composed of:

1. inherent safety by design

2. protective measures

3. information for safety

The article can be found here.

Posted by Dr. Tim Sandle