Using Agile in SaMD Development Under IEC 62304

Uncovering how Agile practices fulfill Software as a Medical Device Development
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What is FDA's 21 CFR Part 820?

Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
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The Ultimate SaMD Development Plan

Easy ways to meet FDA Regulatory Requirements with your Software Development Plan
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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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