EUMDR Regulation | MDR Quality Management System

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

Based on the European Union’s ruling regarding the new Regulation (EU) 2017/745, medical device companies must revise their processes, including their Quality Management Systems (QMS). Implementing a quality management system is as much an art as it is a science, though. It requires keen analytical skills as well as data integrity skills and the ability to engage people. It takes a methodological approach as well as strategic creativity.

EngineeringNXT Preparing for Regulation (EU) 2017/745

Quality Management Principles

Based on the International Organization for Standardization’s (ISO) 2015 revision*, Quality Management Systems are comprised of seven main principles, each of which must be analyzed during this process.

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

Part of the art of conducting a good gap analysis and remediation involves working closely with the staff charged with monitoring and modifying the QMS system as well as getting buy-in for the process so that all parties feel that they are on the same side of the table working in harmony to achieve compliance excellence.

Recently, Wipro had the opportunity to partner with an organization going through this process. By tackling each step of the process thoughtfully and carefully, we were able to successfully remediate their QMS - and now we’re sharing our learnings with you via this white paper.

In this white paper, we cover important topics including:

+ The key objectives of the new MDR regulations

+ The most significant shifts moving from MDD to MDR

+ A case study involving one of our customers shifting to MDR standards

+ Updates and newly created processes based on these changes

+ And more