Chicago Chapter: Interrelationships and Interactions: EU MDR, QSR, ISO 13485 (2016) Quality System a

When:  Apr 25, 2019 from 5:30 PM to 8:30 PM (ET)

Thursday, 25 April 2019
5:30–8:30 pm CDT
AbbVie One
26525 North Riverwoods Blvd
Conference Room Paris
Mettawa, IL 60045-3440
+1 800 255 5162

EU MDR, QSR, ISO 13485 (2016) and MDSAP take effect in the year 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, hosted by AbbVie Inc., is brought to you by the RAPS Chicago 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

Registration Fees:
RAPS Members: $30
Nonmember: $45


26525 N Riverwoods Blvd
Mettawa, IL 60045-3440