Preparing for Regulation (EU) 2017/745

Remediating Quality Management Systems (QMS) to Meet New MDR Standards in the EU

 


Preparing for Regulation (EU) 2017/745

Remediating Quality Management Systems (QMS) to Meet New MDR Standards in the EU

 

The Expectation for Medical Devices in the EU is Changing

EUMDR

Quality Management Principles






Customer Focus

Meeting customer expectations and retaining their confidence






Improvement

Placing value on continued growth and development






Leadership

Providing the direction necessary to inspire employees and produce quality product






Evidence-Based Decision Making

Settling on decisions through facts and analysis versus impulse






Engagement of People

Ensuring employees are adequately trained and cared for






Relationship Management

Maintaining positive relationships with all interested parties






Process Approach

Maintaining a measurable, regimented approach to systems

Adapting to These New Regulations