The clock is ticking!
The deadline for compliance with the new European Union Medical Device Regulation (EU MDR) has been changed to May 26, 2021, but don’t get complacent. The significant effort involved, combined with ineffective program and transition change management approaches to structure, plan, and manage the work, may still result in in delays and business risks.
Learn how to accelerate your EU MDR compliance to ensure success. Download “EU MDR: Achieving On-Time Compliance with Lasting Benefits,” recently presented by IPM quality and regulatory experts Scott Babler and Tim Ehr at the 2019 American Medical Device Summit.
The presentation covers:
- Building a program structure and scoping the work to meet critical requirements
- Balancing short- and long-term risks to establish priorities
- Assessing your product portfolio to identify changed product risk classifications and applying strategic decision making to eliminate underperforming products
- Revising processes and procedures to meet new QMS requirements and streamline product development to ensure a sustainable compliance program
Service: Quality and Regulatory
Industry: Life Sciences