FDA issued a draft guidance for comment: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Contains Nonbinding Recommendations Draft – Not for Implementation Equivalence through Performance Criteria. The outline shows a Section 17 for software information. The outline can be viewed here.Read More
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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.
