Sierra Labs Blog

By: Sierra Labs on 4/24/23 10:52

What does FDA’s Draft Predetermined Change Control Plan PCCP for AIML-DSF recommend?

Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

By: Sierra Labs on 1/27/22 10:40

5 Easy Steps for SaMD Startups to Successfully Implement a QMS

Learn about setting up a QMS for Software as a Medical Device (SaMD), from planning, documentation, implementation, to control.

By: Sierra Labs on 1/15/22 12:23

Architecting Atlassian for Healthcare and FDA Compliance: Part 1

Bridging the gap between agile development for innovation and audit readiness for compliance!

By: Sierra Labs on 1/13/22 12:34

Architecting Atlassian for Healthcare and FDA Compliance: Part 2

Using Atlassian’s Jira framework to transform and boost DevOps!

6 Steps to Implementing a QMS Software for Life Sciences

By: Sierra Labs on 9/16/21 11:16

6 Steps for Implementing a QMS Software

Learn the right steps to adopting an eQMS for your Medical Device or Life Science organization.

By: Sierra Labs on 1/14/21 10:58

Pro Tips Surrounding Design Controls for Medical Devices

Breaking Down Design Control Requirements for Medical Device Development Teams

By: Sierra Labs on 11/12/20 12:24

What Atlassian's Elimination of Jira Server Means For Your Business

How the transition from Jira Server to Jira Cloud will impact Healthcare and Life Science Companies