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 07/09/19 10:58

A simple breakdown of the Software Pre-Certification Program and how it affects your company.

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

A quick and easy rundown of ISO and IEC standards.

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 04/02/19 16:32

Breaking down the basics of Software as a Medical Device (SaMD): risk categorizations and examples.

By: Sierra Labs on 03/27/19 11:19

Learn how to implement Agile into your SaMD development and also stay compliant.