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
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.