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eQMS Validation

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 for its intended use and that it’s trustworthy and reliable. 


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