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We provide you with free information like templates, white-papers, guidance and posters. Have a look and get informed. We will post up-coming regulatory need-to-know information here.

IVDR (EU) 2017/746

Template: Declaration of Conformity

Template: Checklist IVDR Technical Documentation (short)

Template: Checklist IVDR Technical Documentation (extensive)

Template: Checklist of Harmonized Standards

Template: General Safety and Performance (GSPR) Checklist