Click here to view a summary of my highlights and rationale, along with some practical implementation tips for the new ISO 13485:2016: SoftwareCPR-ISO13485 revision March 2016 highlights Some of the revisions add items included in FDA’s 21 CFR 820 Quality System Regulation such as Design Transfer, Validation of automation of quality system activities, detailed records, and...Read More
“Being Agile & Compliant”
2-day Public Training Course
Tampa, Florida USA
Feb 18-19, 2019
Come meet John F. Murray, Jr., who recently retired from FDA and joined SoftwareCPR®, at the course!
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