How to validate an eQMS

How to validate an eQMS

In this video, Jacob Sjørslev talks about what is needed to validate an eQMS. This validation activity is needed according to ISO13485:2016 7.5.6, 21 CFR Part 11 Subpart B and Annex 11. The goal is to establish a level of confidence that the software is appropriate...
How to implement an eQMS

How to implement an eQMS

If you are a Medical Device manufacturer, for sure you have a Quality Management System (QMS). But the next question is more about the technology you are using to keep this QMS alive. Is it the old paper or is it a digital solution? In this episode of the Medical...