EU Finalizes New Medical Device RegulationA Q1 Productions 2017 White Paper
CHAPTER ONE: QUALITY MANAGEMENT SYSTEMS
The MDR contains explicit requirements for manufacturers to establish, implement, and manage a quality management system (QMS). While ISO 13485 is not required under the MDR, it is the recognized industry standard for comprehensive product design and manufacturing and can be implemented concurrent to the Regulation. An effective QMS must contain risked-based decision making processes and procedures for complying with evolving regulations, while monitoring delegated acts that might change the essential requirements.
To read more about the aspects that the quality management system shall address, download our whitepaper.
The six topic areas we will cover include changes to the following:
Surveillance and Vigilance
This paper looks to provide a summarized overview of the provisions within the regulation which will impact medical device manufacturers—from CE marking and technical document management to quality management systems.