QMS Software
Recommendations for EU-compliant electronic signature systems for medical device documentation
Our company is seeking recommendations for electronic signature systems that comply with EU requirements (no FDA considerations for now). We currently use a validated internal...
How should code editors like VS Code be validated in SaMD development?
For companies developing Software as a Medical Device (SaMD), is it necessary to validate code editors such as Visual Studio Code as part of the QMS software tool validation?...
What's The Best QMS Software?
We're looking for QMS software and don't know which one to choose. Which one is the best QMS software?y
Can We Integrate Our eQMS With Jira, GitHub, Sharepoint, etc.?
We'd like to integrate our eQMS with our development tools like e.g. Jira, GitHub, Sharepoint and others. Does that make sense and how should we set it up?
Which QMS Software Should We Choose?
We're a startup developing software as a medical device and we're wondering which QMS software to choose. They all seem so similar.
What Is "FDA 21 CFR Part 820" Compliant eQMS Software?
We are a startup and are in the early stages of getting our medical device FDA approved. We are currently looking at eQMS software to manage our QMS process. We have to adhere...
How To Create a QMS in Sharepoint: Complete Guide + Don't Do It
We’re already using Microsoft software for our company, like Teams and Office. Now need to set up a Quality Management System (QMS) for our medical device which must comply with...
QMS Software And Jira / GitHub / GitLab Integrations: Don't Make a Mistake!
We’re looking for QMS software. It’s important for us that it has a Jira / GitHub / GitLab integration because our development and project planning happens in one of those...
How Can We Set Up a QMS in Confluence / Jira?
We’re already using Confluence and Jira for our development planning. Now we need to set up a Quality Management System (QMS) for medical device compliance (e.g. ISO 13485). Can...