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 AM
|
Introduction
|
Ramesh Annayappa, Celegence
|
|
11:05 – 11:15 AM
|
Optimizing your legacy device strategy for EU MDR
|
Sophie Vaillot, Nobel Biocare
|
|
11:15 – 11:30 AM
|
Notified Body perspective: Virtual audit preparation &
considerations
|
Dr. Royth, TÜV SÜD
|
|
11:30 – 12:30 PM
|
Panel Discussion / Q&A with:
|
|
|
|
·
Jim Talbot, Zap Surgical
·
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