Standards Navigator

In addition to information on existing standards, the SoftwareCPR Standards Navigator subscription keeps you up to date on new standards activity and gives you expert insight into future changes to existing standards.  Draft standards are available on a limited basis to subscribers to provide input to SoftwareCPR for the purpose of developing a position or comments on the draft.  These draft standards will only be posted until the standards committee review process is complete.

About the author

Partner and General Manager, Brian Pate is ISO 1385:2016 Lead Auditor certified for Medical Device Quality Management Systems (MD), and ISO 19011:2018 Management Systems Auditing (AU) and Leading Management Systems Audit Teams (TL). Brian started his medical device career in anesthesia clinical research in 1985 and has since worked both academia and industry including many years with Johnson & Johnson, Baxter Healthcare, and GE Medical. Brian’s roles have included software engineering, systems engineering, quality assurance, and regulatory affairs. Brian has served on multiple AAMI TIR working groups, including TIR32-2008 (Application of ISO 14971 Risk Management to Software; now IEC 80002-1) and TIR45-2012 (Guidance on the use of Agile practices in the development of medical device software) and served as a reviewer for the 2nd edition of TIR45. Brian serves on the AAMI Software Committee and as an AAMI instructor for the software, design controls, and agile methods courses. Brian also is a member of the Underwriters’ Laboratories (UL) Standards Technical Panel for UL1998 (Software in Programmable Components) and or UL5500 (Remote Software Updates).

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

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

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