March 10, 2020 - March 11, 2020
/ USA - Cincinatti, Ohio
Event: MDR Workshop 2020 by Xavier Health
Date: 10th of March - 11th of March 2020
Location: Cintas Center, Ohio, United States
Qserve's panel member: Gert Bos
Experts Bassil Akra (TÜV SÜD), Philippe AuClair (Abbott), and Gert Bos (Qserve) will lead you through the development of time-critical, actionable strategies for keeping your medical devices on the EU market.
At this workshop, learn and develop plans to:
- Manage concurrent MDD and MDR compliant products, as well as assess the effects of any changes.
- Ensure market continuity for “Legacy” products after May 2020.
- Compile the data required for new technical documentation, submissions and mapping to GSPRs.
- Implement and coordinate post-market data and analysis for proper reporting and trending for mandatory submissions, as well as for compliant QMSs.
- Heighten awareness of the urgency to take action and gain support from senior leaders (CEO, COO, CQO, CFO, Chief Legal Officer, etc.).
Gert Bos will be giving the following workshops:
- Moving Targets and Short Timelines
- The essence of being is to learn as you move along. So, what have we learned from MDR implementation sofar? What is clear, and where is more clarity needed. Is there anything new ahead, additional legislation, guidance documents etc. And how are we dealing with the complexities of the EUDAMED delay, and with the MDR sections on economic operators and PMS that kick in on 26 May 2020 for all products, including legacy products under MDD/AIMD grace period. An interactive session to look forward to!
- Navigating the Gray: Developing Successful Solutions
- Challenges abound due to the relatively low level of development of the MDR interpretations. How to manage areas that lack details or successful solutions. Think of the lack of resources at the notified bodies, and how to strategically work with them. Potentially expand into other markets, but those might be reliant on CE market… And more!
- Technical Challenges within GSPR's
- On first reading, annex I looks simple; a second look finds some hidden trouble; a third look opens a can of worms. How to deal with the GSPR effectively, without starting from scratch with a full new design! This session will get you started!
For more information or to book your ticket, click here.