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SUMMARY:WEBINAR: ISO 13485:2016 & EU MDR/IVDR – From Scope to Certification
DESCRIPTION:ISO 13485:2016 is the backbone of a compliant medical device business and a key enabler for CE marking and international registrations. In this webinar\, we’ll go beyond the basics and show\, in practical terms\, who ISO 13485 applies to\, how it links with EU MDR/IVDR and ISO 9001\, and how it supports market access.Through clear explanations and practical checklists\, we will cover:– The scope of ISO 13485 and affected roles (manufacturers\, ARs\, importers\, distributors)– Its relationship with EU MDR/IVDR\, CE marking\, and registrations in specific markets– The main clauses of the standard and what they expect from you– The essential documents and records you must have in place– The steps to achieve and maintain certification\, and where our service fits into each stage👉 Reserve your spot now and take a concrete step towards a stronger\, ISO 13485-compliant QMS.
URL:https://www.obelis.net/events/webinar-iso-134852016-eu-mdr-ivdr-from-scope-to-certification/
CATEGORIES:Exhibitions
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