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everything you need to know
DOWNLOADS
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.
MDR (EU) 2017/745
Template: List of Applicable Standards
Template: General Safety and Performance (GSPR) Checklist
Template: Checklist of Harmonized Standards
IVDR (EU) 2017/746
Template: Checklist IVDR Technical Documentation (short)
Template: Checklist IVDR Technical Documentation (extensive)
Template: Checklist of Harmonized Standards
Template: General Safety and Performance (GSPR) Checklist