Day

October 11, 2015
https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edition-health-information-technology-certification-criteria-2015-edition-base-electronic
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https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edition-health-information-technology-certification-criteria-2015-edition-base-electronic
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A committee draft for vote has been circulated for the AAMI TIR 57 Principles for medical device information security risk management. The objective of this TIR is to provide guidance on how medical device manufacturers can manage risks from security threats that could impact the confidentiality, integrity, and/or availability of the device or the information...
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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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