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November 4, 2021
Nothing software specific in this guidance, Manufacture-of-Blood-Components-Using-Pathogen-Reduction-Device-2021, but in the future one might envision that the validation and quality control could be automated by software. Purpose of the document is to provide guidance to establishments that collect or process blood and blood components, with recommendations for implementing a pathogen reduction device for the manufacture of...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

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Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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