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.
Kim Trautman, MS, executive vice president, medical device international services, NSF International
Local contact: Lena Cordie-Bancroft, Twin Cities Chapter Chair
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
Photo Release: By registering for this program, you acknowledge that your picture may be taken by RAPS agents and consent to the use of your name and likeness by RAPS for any RAPS use as deemed appropriate by the organization.
Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at firstname.lastname@example.org.