EU MDR Application Process: Notified Body, Industry, and Internal Auditing Perspectives
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New England Discussion Group (NEDG) Seminar –
EU MDR Application Process: Notified Body, Industry, and Internal Auditing Perspectives


Is your company going through or about to go through the EU MDR certification process? Hear about the EU MDR application process from the perspectives of a Notified Body, medical device industry experts and an EU MDR internal auditor. Learn:
  • What is required for obtaining EU MDR certification from the perspectives of a Notified Body – from initial customer application to getting the certificate with a specific focus on the MDR upgrade/stage 2 process.
  • The requirements of the EU MDR Article 120 for a valid MDD certification that has not yet expired.
  • Actual industry experience from colleagues that have successfully navigated the EU MDR application process and received MDR certification.
  • Internal audit preparations.
Presenters:
  • Marie-Sarah Brunet, BSI Service Delivery Manager - EU MDR Application Process from the Notified Body Perspective, with Focus on the Stage 2 Initial QMS process. Also, requirements for MDR Article 120.
  • Julie Perkins, VP Regulatory Affairs, Insulet Corporation - Experience with EU MDR Application Process from an Industry Perspective (Insulet recently received MDR certification from BSI)
  • Tina Lochner, Senior Manager RA, Draeger Medical System - Experience with EU MDR Application Process from an Industry Perspective (Draeger recently received MDR certification from TUV Süd)
  • Debbie Iampietro, Independent QA/RA Consultant - EU MDR Internal Auditing
Date:
January 9. 2023, 3:30 PM – 8:00 PM (Registration – 3:00 PM)
Date & Time
Monday January 9th, 2023 2:30pm CST
End Date & Time
Monday January 9th, 2023 2:30pm CST
Venue
Waltham Woods Conference Center
Address
860 Winter Street
Waltham, MA 02451
United States
Categories
Conference, Meeting
Host Type
Technical
Category Public Calendar

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Date & Time: 01/09/2023 02:30:00 PM CST

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