Is it possible to view draft revisions of FDA guidance documents when they are a “work in progress,” or are they only become available once published as draft? This is a frequent question that I have heard. However, the FDA does not typically provide copies or drafts of “works in progress” for those items that...Read More
Latest News!
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.