A Simple Guide to 510(k) Applications for Medical Devices
Easy Guidance for Abbreviated, Special, and Traditional 510(k) Clearance Applications
Read more
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.
Read more
Architecting Atlassian for Healthcare and FDA Compliance: Part 1
Bridging the gap between agile development for innovation and audit readiness for compliance!
Read more
Architecting Atlassian for Healthcare and FDA Compliance: Part 2
Using Atlassian’s Jira framework to transform and boost DevOps!
Read more
Case Study: Digiteyez Technologies
Digiteyez Technologies uses Sierra QMS to streamline compliance processes and tackle FDA regulations for their medical device, Clear.
Read more
6 Steps for Implementing a QMS Software
Learn the right steps to adopting an eQMS for your Medical Device or Life Science organization.
Read more
Case Study: Transparency Life Sciences
How Sierra Labs and TLS Partnered to Streamline Their Quality Process
Read more
The Ultimate Quality Management System for Life Sciences
Must-Have Features & Functionality for Your Quality Management System (QMS)
Read more
A Regulatory Approach Manual for Device Software Functions
Understanding the policies for your Medical Device Software Functions
Read more