Sierra Labs Blog

By: Sierra Labs on 03/31/22 10:50

A deeper dive into crucial policies for Software for Medical Device (SaMD) Organizations

By: Sierra Labs on 03/03/22 12:30

Leveraging these expectations to ensure the highest level of quality for your Software as a Medical Device (SaMD)

By: Sierra Labs on 12/17/20 11:54

What is the right approach to developing hardware-based medical devices?

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 08/20/20 9:07

Explore the unique challenges and considerations of SaMD 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 11/06/19 12:02

What should be on your radar while tackling GxP Cloud Validation.

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 06/05/19 11:26

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