Essentials of European Medical Device Regulatory Affairs - June 2020

Conformity Assessment Procedures: Annex IX to XI Annex XI • Product Conformity Verification • Linked to type examination • Follow Part A or Part B: • Part A: Production Quality Assurance – QMS (excluding design processes) – Technical documentation • Part B: Product Verification – NB Examines and tests every manufactured device – documented manufacture process – PMS – EU product verification certificate

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Conformity Assessment Procedures - Options

TheOrganisation for Professionals in Regulatory Affairs

Conformity Assessment Procedures - Options

TheOrganisation for Professionals in Regulatory Affairs

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