January 30 – 31, 2024
Munich, Germany
Booth #19
Explore Premier Research’s insights at OCT Medical Device Europe. Gain practical solutions for current clinical trial challenges. Visit our booth and catch our expert’s speaking session for a pragmatic perspective on operational and outsourcing issues in medical device development. Your participation adds value to the shared knowledge at this event.
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