Details
Food, drinks, networking, and a little bit about staying alive in the new world of CERs. MEDDEV 2.7/1 Rev. 4 and the new European Union Medical Device Regulation (EU MDR) have raised a lot of questions in the regulatory and clinical affairs communities. The upcoming EU MDR requires enhanced clinical evidence to support the device – whether you have Class I or Class III products. For products that have been on the market for a long time there may be limited or no clinical studies, and yet, the new EU MDR requires your organization to provide clinical evidence on all your devices. There is no time left to wait to learn about, plan for, and act on these changes. Thepresentation portion of the evening will cover CER basics and allow you to ask R&Q’s expert questions, and also others in attendance. We strongly encourage you to take advantage of this learning and networking opportunity!
Agenda:
- 5p-6p Registration & networking
- 6p-7p Presentation and Q&A
- 7p-8p Networking
Presenter:
Paul Harger, Client Solutions Advisor, Regulatory and Quality Solutions (R&Q)
- 20+ years working with Medical Device companies focusing on Regulatory, Intellectual Property and R&D
- CER-focused profession since MEDDEV inception in 2009
- Served as Co-Chair, Regulatory Committee, MedTech Association
- Rochester Institute of Technology, Six Sigma Yellow Belt
Food and drinks will be provided. See you on February 28th!