The EU MDR introduced higher requirements on pre-market and post-market evidence and will reduce the number of devices and manufacturers approved in the EU in the upcoming three years. This regulation requires both notified bodies and manufacturers to requalify and show their compliance again via initial designation and certification process. During this virtual event, you will receive an update on where we stand with this regulation and firsthand experience from initial certification activities under the new legislative framework. You will get the opportunity to raise your questions and receive answers helping practical and reasonable implementation of the requirements.
A live Q&A portion with the speaker will follow the presentation.
This event is brought to you by the RAPS Utah Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.5 RAC recertification credits.
Learning Level: Advanced and Intermediate
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.
How Do Webcasts Work?
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speakers will follow the presentation.
About Your Presenter(s):
Dr. Bassil Akra Chief Executive Officer, Akra Team
Robert Dostert Sales Manager, Medical Devices, DNV
Thank you to our Platinum Chapter Sponsors:
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.
Registration fees for this event are nonrefundable.
Paid registration substitutions may be accepted with written approval from RAPS for requests received within 48 hours of the start of the event. To transfer a registration, email firstname.lastname@example.org with the event title, name of the original registrant and the contact information for the new attendee.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email email@example.com