In April 2019, FDA released a draft guidance providing manufacturers and FDA staff with detailed recommendations on assessing the technical performance of quantitative imaging devices and how the documentation from those assessments should be provided in premarket submissions. From a big picture perspective, one should remember the overall goal is to “provide performance specifications for...Read More
John F. Murray, Jr, will be teaching at our June 4-6, 2019, FDA and 62304 Software course in Boston. Our course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.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.