Sierra Labs Blog

By: Sierra Labs on 08/08/19 10:53

An easily digestible overview of ISO 13485 and how it applies to your medical device company.

By: Sierra Labs on 08/01/19 10:56

A simple breakdown of MDSAP, how it can benefit your company, and detailed instructions on how to get started.

By: Sierra Labs on 07/16/19 9:38

How embracing regulations can give you a leg up on your competition.

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

A quick and easy rundown of ISO and IEC standards.

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

Sierra Policies Quick Start video out now!

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

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

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

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

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!