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Are you part of the medical device industry? Are you curious about whether you need a quality management system certification according to the ISO 13485 standard? Read our updated blog article.


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Understanding ISO 13485 - Certification of a Quality Management System Read how the ISO 13485 standard is meant to help medical device companies (primarily medical device manufacturers) set up a QMS.

All medical device manufacturers must establish a Post-market Surveillance system in compliance with the EU MDR or IVDR, even for legacy devices. Here is all you need to know about it.


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Post-Market Surveillance - 10 Questions about PMS & MDR Post-market surveillance (PMS) is an important part of the regulatory framework for medical devices in Europe. Read about the changes introduced by MDR.