Unique Skill ID: KS127326Y1DN7ZCY2ZVQ

Notified Body

A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.

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Combination Products
Corrective And Preventive Action (CAPA)
ISO 13485 Standard
ISO 14971 Standard
Medical Device Directive
Medical Device Reporting
Medical Devices
Sterilization Validation
Title 21 Of The Code Of Federal Regulations
Validation Master Plan

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