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Glossary Term
The process by which a person demonstrates specific knowledge, skills, or abilities in the view of a certifying body. Similarly, the process by which a product or process can achieve certification indicating its suitability for a specific purpose.
Glossary Term
The international quality-management standard for medical device manufacturing. Certification does not certify individual products, but suppliers with ISO 13485-registered production generally support tender documentation more reliably.
Glossary Term
An organisation designated by an EU member state to assess the conformity of products — including in vitro diagnostics — against applicable regulations before CE marking can be affixed.
