How to work with a Notified Body
Selecting a Notified Body to get your medical devices approved for the first time for the European market is a critical decision. Changing your Registrar can be even more difficult. This interactive work shop will give you an inside look at the operation of the Certification Bodies, and lots of information to help you choose a Notified Body that is the best fit for your organization, as well as basic information on European regulatory requirements.
Seminar topics include:
- The Regulatory Environment for Notified Bodies in Europe
- Keys to a successful cooperation with your Certification Body
- Audit finding, appeal process
- Change notifications
- Roll-over strategies
Who should attend?
RA/QA Managers / Management Representatives
About the speaker:
Tamas Borsai is a Division Manager at TÜV SÜD America Inc. Medical and Human Services, with over 15 years of experience in auditing and certification of medical device manufacturers in the U.S., Europe and in Asia. He has also held positions as Country Manager, Technical Certifier and Lead Auditor. His area of technical expertise relates to active medical devices.
Cost: $700.00 (USD)
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