EU MDR Application Process: Notified Body, Industry, and Internal Auditing Perspectives

When:  Jan 9, 2023 from 08:30 PM to 08:30 PM (UTC)
Associated with  Medical Device Division

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)