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After Brexit: The New UKCA and UKNI Marks. What Medical Device Manufacturers Need to Know

March 24 @ 12:30 pm - 1:30 pm

$10 – $25

Educational Opportunity

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

Location:  Webinar

 

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.

 

*Feel free to email questions ahead of time! program@ocra-online.org

 

 

Cost:

  • 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

 

Speaker Bio

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.

 

 

OCRA Registration Instructions

 

It is important that you register with the name and email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance.

 

Certificates of attendance will be emailed within a day of the event. 

 

Registration deadline is March 23rd.  There is no same day registration.

 

OCRA’s non-profit Federal Tax ID# 33-0630455

 

Cancellation Deadline:

For a refund, please email your cancellation request to OCRA Program Chair (program@ocra-online.org) by March 20, 2021. 

If you have any questions or require additional information, email OCRA Program Chair (program@ocra-online.org). 

 

Details

Date:
March 24
Time:
12:30 pm - 1:30 pm
Cost:
$10 – $25
Event Categories:
,
Website:
https://ocra-dg.org/event/after-brexit-the-new-ukca-and-ukni-marks-what-medical-device-manufacturers-need-to-know

Venue

Online

Tickets

The numbers below include tickets for this event already in your cart. Clicking "Get Tickets" will allow you to edit any existing attendee information as well as change ticket quantities.
OCRA Member Ticket
$ 25.00
Unlimited
Government and Student Members Ticket
$ 10.00
Unlimited