ISO 13485 Management system for medical devices
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- ISO 13485 Management system for medical devices
Interested in Learning How NSAI Can Help Your Company Become ISO 13485 Certified?
ISO 13485 is the internationally recognized standard for a comprehensive management system for the design and manufacture of medical devices. It is often seen as the first step towards achieving compliance with European, Canadian and other regulatory requirements for medical device manufacturers.
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You may also be interested in CE Marking, which is your declaration that the product complies with the Essential Requirements of the relevant European Legislation. By having a CE Mark, you will have immediate access to all EU and EEA Markets as well as any other international markets where CE Marking is accepted.
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