On-demand On-demand

The Aftermath of MDR

1.0 RAC Credits Member: $0.00 Nonmember: $20.00
The Aftermath of MDR

This is an On-demand recording from November 2021


This webcast covers the experiences of industry early adopters of the EU Medical Device Regulation (MDR) alongside the Notified Bodies. The program includes insights from off-the-record interviews held with both manufacturers and notified bodies to identify areas of misalignment and challenges they are facing during this transition period. It features examples of real products under MDR technical file review to add valuable insight to industry on the array of challenges.

Learning Objectives

At the conclusion of the webcast, participants should be able to:

  • Provide real life examples from products going through this transition period
  • Identify areas where industry is consistently making mistakes from the Notified Body perspective
  • Review appeals pathways or other options if opposing opinions arise
  • Provide valuable insight on how industry can align with the expectations of Notified Bodies under MDR

Pricing Amounts & Deadlines 

Complimentary

Who Should Attend? 

Any industry representative that is either in the EU now or intending to pursue commercialization in the EU market.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.


Speaker(s)

Michelle Lott

leanRAQA

Michelle Lott is founder and principal of leanRAQA. She has supported more than 100 companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence and technical support services. Lott’s clients delegate these things to her so they can focus on winning in the marketplace. She served a four-year term on the US Food and Drug Administration (FDA) Device Good Manufacturing Practices Advisory Committee (DGMP), and she has completed the RAPS Executive Development Program at the Kellogg School of Management at Northwestern University.


Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to support@raps.org. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 


Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.


Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org  
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