Checklists

This topic provides educational checklists related to several standards and regulations. SoftwareCPR checklists are available to paid subscribers of www.softwarecpr.com by using their login. These are only intended for use by those experienced in the related regulations and standards and are not intended to be used blindly as there may be significant interpretational ambiguities and evolving enforcement. Checklists issued by FDA itself that are included here are available to everyone as public information (without a login). Older or special topic checklists issued by FDA are available in the document library portion of this website.

SoftwareCPR Training Courses:

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

Or just email training@softwarecpr.com for more info.

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