Event
OCT Medical Devices EU
Visit Premier Research at OCT Medical Device Europe. This event will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials.
The Power of Clinical Data: What Medical Device Developers Need to Know About MDR Article 61.4
January 31, 2024
9:30 a.m.
- An overview of MDR Article 61.4, with a focus on performance and safety requirements for a clinical investigation of implantable and class III devices
- The impact on claiming equivalence, and the challenges med device sponsors are facing
- Key considerations for operationalizing medical device clinical investigations to achieve performance and safety data
Speaker: John Thomas, Director, Program Delivery, MedTech