Sierra Labs Blog

By: Sierra Labs on 5/11/23 11:04

Easy Ways to Meet FDA Regulatory Requirements with Your Software Development Plan

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 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 6/26/19 17:43

A quick and easy rundown of ISO and IEC standards.

By: Sierra Labs on 6/17/19 16:27

Sierra Policies Quick Start video out now!

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

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