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Keywords: certificates of conformity, conditional approval, high-risk medical devices, Notified Bodies, Medical Device Regulation 2017/745 Citation: Dobrzynska A, Rejon-Parrilla JC, Epstein D, ...

A Declaration of Conformity (DoC) is a document stating that a product meets the legal standards to which it must adhere, such as safety regulations.

The Certificate of Analysis (CoA) is a crucial Good Manufacturing Practice (GMP) document for a batch of drug substances or products in development or production. It contains essential quality ...

CPSC unveils proposed changes to Certificates of Compliance, including mandatory eFiling, expanded importer definitions, and new content requirements ...