What is this webinar about?

This webinar will cover BSI’s approach to the transfer of MDR/IVDR/UKCA certified devices from a previous Notified/Approved Body to BSI.  It will also cover transfer of MDR/IVDR devices already in application with a previous Notified Body moving to the BSI Notified Body.  We discuss key steps in BSI’s Certification Transfer Process for CE certification under the MDR/IVDR and UKCA certification under UK Medical Devices Regulation. 

What will participants gain?

A high-level overview of the new BSI Transfer Process for MDR/IVDR/UKCA certification, with a focus on leveraging reviews and PSURs as the primary approach.  Participants will learn how to get started with the new BSI Transfer Process.

Who should attend?

Manufacturers of medical devices and IVDs looking to transfer in their current MDR/IVDR/UKCA certificates to BSI, as well as any devices in application for MDR/IVDR certification.

Speakers

Dr Purvi Patel
Regulatory Lead
 
 
John Bis
Commercial Operations Director - Regulatory Services, Americas

 

To learn more about transferring your certification to BSI and our '5 Steps to Transfer', click here

Email: us.medicaldevices@bsigroup.com

Phone: +1 888 429 6178

 

 

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