EU Medical Device Regulation (MDR) 2017/745 – QMS Auditor EN

The Medical Device Regulation (MDR) is the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union.As more and more manufacturers now have their MDR Quality Management System (QMS) certificates, it’s imperative for continued compliance that they are able to perform audits against the requirements of the QMS MDR.This course is designed to give you insights into how Notified Bodies may perform an MDR QMS compliance audit, using the topics of a typical MDR audit agenda as the basis. This will enable you to optimize your auditing skills and knowledge to boost your audit capabilities, gain confidence in planning and performing an effective EU MDR QMS audit, as well as ensuring continued compliance to the EU MDR (2017/245).   Course Outcomes   By the end of the course you’ll be able to:• Establish the relationship between the ISO 13485:2016 and the EU MDR (2017/745)• Recognize and interpret the key QMS requirements of the EU MDR (2017/745)• Appreciate that the range of medical device classifications mean differing requirements in the context of auditing• Plan for and conduct EU MDR (2017/745) QMS audits to establish and maintain compliance against these requirements• Report on any identified nonconformities