The link provided is to an article on mobihealthnews.com summarizing the congressional hearing last week on whether software should be regulated by FDA as a medical device. This is related to the Blackburn Bill which would exempt many standalone software medical applications, if passed into law, from FDA regulation.
IEC 62304 and other Emerging Standards Impacting Medical Device Software
Being Agile & Yet Compliant
ISO 14971 SaMD Risk Management
Software Risk Management
Medical Device Cybersecurity
Software Verification
IEC 62366 Usability Process and Documentation
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