Blog

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 ...
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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 ...
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SimplerQMS Customer Case: Reapplix

The medical device company Reapplix is using SimplerQMS to work efficiently with their regulated quality documentation. SimplerQMS is an ISO13485 ...
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How To Comply With Part 11 Electronic Signatures

Learn about the requirements for using Electronic Signatures, which are compliant with FDA 21 CFR Part 11. The Part 11 ...
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Why choose SimplerQMS as your eQMS?

Our vision is to be a preferred partner for small life science companies, that focus on high quality and efficient ...
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3 Lessons Learned From 15 Medical Device Startup’s

During the past months we have met with founders of 15 medical device startup’s in order to learn about their ...
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Medical Device Start-up’s fear migrating to eQMS

Switching to a modern digital eQMS from a paper-based QMS will save a medical device start-up time and money by ...
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5 reasons to replace your paper-based QMS with an eQMS

The regulatory requirements for medical device startups are significant. It’s imperative for your business, not to be ‘killed by paper’ ...
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