EUDAMED compliance requirements under the European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) are coming, and medical device manufacturers need to be building their global compliance strategy now. Companies that successfully build a compliance strategy to future-proof their data management processes will stay ahead of any new regulatory requirements that arise.
The discussion will include:
About the Presenter:
- What device manufacturers did to comply with the US FDA UDI rule and should DO again
- What device manufacturers did to comply with the US FDA UDI rule and should NEVER DO again
- How to build compliant systems, structures, and processes to manage future variations and expanded requirements beyond post market surveillance
Vice President of Unique Device Identification Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.