Taking Advantage of the EU MDR Delay in Uncertain Times: Optimizing Your Medical Device RA/QA Strategy

1.5 RAC Credits On-demand Member: $0.00 Nonmember: $20.00

This is an On-demand recording from July 2020 

Is your organization facing hurdles regarding MDR certification? What about recertification under MDD? Join RAPS and Celegence for a webcast where regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges - both past and future - related to EU MDR.

During the discussion panel, you will have the opportunity to ask questions and develop a comprehensive and advanced understanding of potential strategic solutions for MDR compliance, regardless of where you are in the transition process. You will also learn how to take advantage of the extension for both MDD renewal and MDR implementation.

Join us and get your questions on MDR certification and recertification under MDD answered by Celegence experts.

 

Agenda:

11:00 - 11:05: Introduction - Ramesh Annayappa, Celegence

11:05 - 11:15: Optimizing your legacy device strategy for EU MDR - Sophie Vaillot, Nobel Biocare

11:15 -11:30: Notified Body perspective: Virtual audit preparation & considerations - Dr. Royth, TÜV SÜD

11:30 -12:30: Panel Discussion / Q&A with:

·         Carlos Munoz-Viveros / Kavo Kerr

·         Gregory Shipp / Bausch Health 

Learning Level: Intermediate

Learning Objectives

• Upon conclusion of the program, you will:
• Gain an understanding of what the EU-MDR extension means for your organization, and how the extra time should be leveraged for both new and legacy devices.
• Know how to strategically plan for upcoming audits based on common NB findings and pitfalls.
• Understand the beneficial tactics you can use in a virtual audit.
• Grasp how to use the time to work with NBs, Economic Operators, and implement all recently published MDCG Guidance.
• Be able to strategically plan for interactions with specific extra-EU situations: Switzerland and Turkey.

Who Should Attend?

• Quality managers
• Regulatory managers
• Technical Writers
• Operations managers
• Design managers
• Technical managers

Your Speakers

Ramesh Annayappa, associate director (medical device services), Celegence

Sophie Vaillot, global head of regulatory affairs, Nobel Biocare

Dr. Royth von Hahn, senior vice president medical & health services, TÜV SÜD Product Service Division