Implementing Effective and Compliant Quality Management Procedures under the EU MDR through Analysis of Post Market Regulatory Requirements, Risk Mitigation throughout the Supply Chain and Increased Economic Operator Oversight
With the deadline for full implementation of the European Medical Device Regulation drawing near, limited company resources, a lack of regulatory guidance and overburdened notified bodies have made the transition a substantial challenge for medical device companies, particularly for quality assurance professionals. The wide scope of the EU MDR impacts both internal and external aspects of a company’s quality processes. As teams work to update quality manuals to implement new methods of complaint processing and post-market surveillance, previously established supplier agreements are also being scrutinized to assess whether partnering companies are meeting new standards on hazardous materials and other design controls.
In order to address these wide range of tasks, the EU MDR: Quality System Alignment Conference will provide quality assurance professionals with techniques to identify key work streams necessary to guide the application of new procedures and protocol. The program will provide teams with methods of pinpointing non-compliant procedures through revised risk assessment practices, while giving a comprehensive assessment of the EU Commission’s expectations on post market concerns such as labeling and proper documentation. Through panel conversations and in-depth case studies, the conference aims to leave attendees with an extensive understanding of the many ways quality management systems are impacted by the MDR and gain valuable insight into tactics that will ensure implementation before the deadline arrives.