As the new Medical Device Regulation (MDR) brings significant requirements for technical documentation, clinical data, quality management systems and more, experts predict that approx. 30% of companies may go out of business.
Device manufacturers, especially those that have grown through acquisition, having, in some cases, decades of legacy documents, processes, and systems, may struggle to keep up with the constant traceability and transparency that the new regulation stipulates.
Forward-thinking companies see the new regulation as an opportunity to harmonise and modernise processes and technology to gain market advantage.
This white paper examines challenges and opportunities that arise post the Date of Application (DoA), and outlines business areas for improvement to ensure long-term compliance, including:
- Addressing MDR influence on MedTech innovation capabilities
- Driving operational modernisation within the business
- Achieving unified and connected regulatory environments
- Managing compliance: examples of modern approaches from leading device companies
About the author:
Annemien Pullen, PhD
Director Strategy, Veeva MedTech Europe
Veeva MedTech
With more than 10 years of experience in the industry, Annemien has a deep understanding of the E2E device development process and regulatory transformation. After her PhD in Interorganisational Collaboration in Medical Device Product Development, she led a number of MDR business transformation programs.