Twin Cities Chapter: Interrelationships and Interactions: EU MDR, QSR, ISO 13485 (2016) Quality System and MDSAP

RAC Credits
Wednesday, 24 July 2019 (5:30 PM) - Wednesday, 24 July 2019 (8:30 PM) (Central Time (US & Canada))
5801 Opus Pkwy
Minnetonka, Minnesota, USA, 55343-9680

Member: $60
Nonmember: $75

EU MDR, QSR, ISO 13485 (2016) and MDSAP take will all take effect in 2020. Now is the time for medical device manufacturers to update their procedures, technical documents and processes to meet the changing global standards and regulations.

Join others from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent pre and post-market requirements for medical device manufacturers, regardless of risk classification. This interactive session will explore strategies to help manufacturers navigate the complex marketplace. Topics to be covered will include:

• Key differences between the new regulations EU, US and MDSAP
• The additional scrutiny in the pre and post-market phase
• Compliance with MDSAP
• How to ensure a smooth transition

This program is brought to you by the RAPS Twin Cities Chapter and is intended to promote knowledge sharing and engagement with others in the in your region. Dinner will be provided and RAC holders may claim two RAC recertification credits.

Featured Speaker:
Kim Trautman, MS, executive vice president, medical device international services, NSF International

Win a complimentary registration to RAPS Regulatory Convergence!
During this event, we'll hold a raffle for a complimentary registration to the 2019 Regulatory Convergence in Philadelphia. You must be present to win.