Tag

devops
26
Jun

DevOps and SaMD Practices

June 26, 2019,
As more “software as a medical device” (SaMD) applications are developed and marketed, there has been an increased focus on what activities and documentation are required for compliance with US medical device regulations and applicable ISO standards.  Along with the rise of SaMD has come the emergence of supporting organizational, management, and production activities that...
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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

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

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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