Changing Regulatory Expectations: Events that Shaped the New EU Medical Device Regulation and Changed Expectations

The only thing you can count on in life, is change.  The Medical Device Community is living amid this reality.  Last year the new EU Medical Device Regulation 2017/745 (MDR) was published. Medical Device Manufacturers have until 2020 to come into compliance with the new requirements. This white paper will highlight some of the events of the past decade that helped shape the new regulations and led to heightened regulator expectations. Upon reviewing the new requirements, it is clear.  It will be more important than ever to have a strong robust Quality Risk Management System if you hope to meet changing expectations.  This paper will highlight key aspects of a strong QRM program and help you evaluate your current program.