What is ISO 13485:2016?
An easily digestible overview of ISO 13485 and how it applies to your medical device company.
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Medical Device Software & SaMDs: A Crash Course
A quick and easy rundown of ISO and IEC standards.
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New Medical Device & Life Science Collaboration Platform
Sierra Policies Quick Start video out now!
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ISO 13485 vs. CFR Part 820
A comparative study on the key differences between FDA’s QSR and ISO’s QMS.
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