Sierra Labs Blog

By: Sierra Labs on 11/05/20 12:32

Understanding the difference and benefits between ISO and IEC Standards for Software as a Medical Device

By: Sierra Labs on 09/10/20 9:07

Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.

By: Sierra Labs on 07/16/20 12:57

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

By: Sierra Labs on 07/02/20 11:56

Easy ways to meet FDA Regulatory Requirements with your Software Development Plan

By: Sierra Labs on 04/09/20 11:48

How to utilize ISO 13485 to acquire a CE Marking on your Medical Device.

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 07/16/19 9:38

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

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

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