Sierra Labs Blog | ISO

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Medical Device Software & SaMDs: A Crash Course

By: Sierra Labs on 06/26/19 17:43

A quick and easy rundown of ISO and IEC standards.

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New Medical Device & Life Science Collaboration Platform

By: Sierra Labs on 06/17/19 16:27

Sierra Policies Quick Start video out now!

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ISO 13485 vs. CFR Part 820

By: Sierra Labs on 06/05/19 11:26

A comparative study on the key differences between FDA’s QSR and ISO’s QMS.

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ISO 14971 Risk Management in Under 5 Minutes

By: Sierra Labs on 05/14/19 9:51

Defining medical device risk while taking a sneak peek into ISO 14971:2019.

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Shape the future of FDA Regulations for AI/ML.

By: Sierra Labs on 05/03/19 10:54

The proposal for AI/ML based SaMD regulatory framework is out now and you can influence the FDA!