The entire medical device community has been dealing with the new European Union Medical Device Regulations (EU MDR) for the last few years. The journey has been a struggle for many. Unexpected challenges have emerged in the fields of project management, cross-functional team harmonization, supplier coordination, CER, PMS, and non-EU regulatory submission space. These challenges have come forth as the bi-product of remediating large volumes of documents within a finite duration. Strong project management, communication, and collaboration protocols, and gap assessment strategies would form the pillars of a successful EU MDR transition.
Read our whitepaper to learn about:
- The unexpected challenges faced during the EU MDR transition
- Possible solutions and best practices to overcome these challenges
- Real-life scenarios and examples to highlight the advantages the presented solutions