How to identify and analyze risk control options and implement those risk control measures that reduce risk as far as possible, without adversely affecting the benefit-risk ratio.
Tag: EU IVDR
Medical Device Regulations Part 2 — Europe
An introduction to The European Union Medical Device Regulation (EU MDR) 2017/745, CE certificates and the companion standard European Union Invitro Diagnostic Regulation (EU IVDR) 2017/746.