Skip main navigation (Press Enter).
Log in
Toggle navigation
Search Options
Log in
Home
Communities
My Communities
All Communities
Directory
Events
Browse
Discussion Posts
Library Entries
Blogs
Getting Started
Help/FAQs
Mentor Match
Mentor Match Instructions
Enroll as a Mentor
Enroll as a Mentee
Mentoring Directories
Mentoring Relationships
Mentor Match FAQs
Volunteer Hub
Welcome to Volunteering!
Volunteer Opportunities
Volunteer Leaderboard
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)
Download to Your Calendar
Copyright 2023. All rights reserved.
Powered by Higher Logic