+++ Latest NEWS: New opinion of IVD Expert Panel +++ Latest DOCUMENT in our Library -EURL fees, criteria, tasks +++ IVDR Regulatory Strategy: implementation guide in STORE now +++ WEBINAR on Legacy devices +++ Our memberships give access to our comprehensive Library of documents, News section, regulatory alerts,...
+++ Latest NEWS: New opinion of IVD Expert Panel +++ Latest DOCUMENT in our Library -EURL fees, criteria, tasks +++ IVDR Regulatory Strategy: implementation guide in STORE now +++ WEBINAR on Legacy devices +++ Our memberships give access to our comprehensive Library of documents, News section, regulatory alerts,...

We make European MDR and IVDR

Did you know that QMS as per ISO 13485:2016 requires to have a system in place to monitor relevant regulatory requirements and related changes ?
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