Sierra Labs Blog

By: Sierra Labs on 7/29/20 9:12

Uncovering how Agile practices fulfill Software as a Medical Device (SaMD) Development

By: Sierra Labs on 7/16/20 12:57

Unpacking the FDA guidelines and regulations under 21 CFR Part 820.

By: Sierra Labs on 4/22/20 14:51

Automation Myths standing in the way of progress in our healthcare system.

By: Sierra Labs on 4/16/20 9:07

Uncover which regulatory pathway is right for your medical device!

By: Sierra Labs on 8/8/19 10:53

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

By: Sierra Labs on 7/16/19 9:38

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

By: Sierra Labs on 7/9/19 10:58

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

By: Sierra Labs on 6/26/19 17:43

A quick and easy rundown of ISO and IEC standards.

By: Sierra Labs on 6/5/19 11:26

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

By: Sierra Labs on 4/2/19 16:32

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