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After Brexit: The New UKCA and UKNI Marks. What Medical Device Manufacturers Need to Know
March 24, 2021 @ 12:30 pm - 1:30 pm$10 – $25
After Brexit: The New UKCA and UKNI Marks.
What Medical Device Manufacturers Need to Know
March 24, 2021
12:30 pm – 1:30 pm PST
1.0 Hours Towards Your Continuing Education
Speaker: Kim Trautman, Executive Vice President, Medical Device International Services, NSF International
Program Manager: Deborah Madsen, Madsen QRC, LLC, Regulatory and Quality Consultant
Brexit is now over and as of January 1, 2021, medical device manufacturers are officially in a transition period until June 30, 2023. However, you must understand the current requirements for UK MHRA registration, obtaining the services of a new UK Approved Body, and working toward affixing the new UK CA or UK NI mark on medical devices entering Great Britain. Further, UK MHRA will not be utilizing the EU MDR or EU IVDR after the transition period but drafting brand new legislation for their new Medical Device/IVD approval scheme. While everyone is focused on the EU – do not forget the Great Britain market and these new requirements.
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- OCRA Members: $25
- Non-Members: $100, includes 1-year OCRA membership
- Government and Student Members: $10, with student/government ID
- Non-Member Government and Student Rate: $45, includes 1-year OCRA membership
Kim Trautman, Executive Vice President, Medical Device International Services, NSF International
Kimberly A. Trautman is an experienced Medical Devices and In Vitro Diagnostics Executive Vice President with over 30 years of experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.
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Registration deadline is March 23rd. There is no same day registration.
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