Tag: GAP analysis

CE marking

2021-02-11

EU MDR Labelling Requirements for Medical Devices

This post focuses on the medical device labelling requirements and user manual requirements under the EU MDR 2017/745.

CE marking

2020-03-18

GAP Analysis: EU MDR Compliance

This article provides a general overview of what a gap analysis is in the context of the Medical Device Regulation (MDR) 2017/745.