Whitepaper: QMS aspects of the Medical Device Regulation
The general QMS requirements, such as internal audits, management responsibility, communication mechanisms, change control and complaint handling, have remained unchanged in the MDR
The general QMS requirements, such as internal audits, management responsibility, communication mechanisms, change control and complaint handling, have remained unchanged in the MDR
The three main areas that must be considered carefully when manufacturers decide to transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) are: Clinical, Quality Management System (QMS) and the Technical Documentation. The aim of this whitepaper is to focus on the major QMS aspects of the MDR, as these are the driver of all changes for the transition.
Download our recent whitepaper to gain deep insights into QMS aspects of the Medical Device Regulation.