The European Medical Device Regulation (EU MDR) introduced significant changes for medical device manufacturers. Obtaining device certification to demonstrate compliance to EU MDR requires significant investment, both in terms of an organization's resources and budget. Most companies see the certification as an endpoint, but in reality, this milestone to establish the device is just the first in the journey to continuously demonstrate compliance and maintain certification.
Companies must properly assess and understand the key process requirements to continue to comply with EU MDR so that they can evaluate the capabilities of allocated resources, budget, and tools. Efficient application of resources following the major projects that drive the EU MDR certification is critical to keep pace and demonstrate the ability to maintain compliance. Manufacturers who discover too late that their systems are under-resourced risk financial burdens, audit findings, and even losing the certification.
Join Hilde Viroux, Consulting Director at PA Consulting, and Adam Price, Director or Product, at Rimsys for a discussion about the elements of successful post- EU MDR compliance and:
• EU MDR requirements post certification
• Key challenges organizations face
• Considerations to make when assessing your organization's preparedness
WHO SHOULD ATTEND:
- Regulatory Affairs Professionals in the MedTech Industry