Sierra Labs Blog

By: Sierra Labs on 8/14/23 11:16

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

By: Sierra Labs on 7/3/23 11:04

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

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 3/21/23 9:07

Explore the unique challenges and considerations of SaMD development.

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 5/14/19 9:51

Defining medical device risk while taking a sneak peek into ISO 14971:2019.

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

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