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TÜV SÜD MHS Roadshow: Influence of the new regulations on the CE Marking Approval in Europe
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08/08/2016
When: Monday, August 8, 2016
Where: MaRS Discovery District
101 College Street
Toronto, Ontario  M5G 1L7
Canada
Contact: Tüv Süd America
1-800-888-0123

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TÜV SÜD MHS Roadshow:  Influence of the new regulations on the CE Marking Approval in Europe

Live 4-hour event, followed by Q&A and networking (food and beverage included)

Attendees will learn about the following:

  • New medical device regulations replacing the current medical device directives in Europe
  • Increased requirements on involved personals and suppliers limiting the market access possibilities in the future
  • New essential requirement checklist requiring a complete update of the technical documentation
  • Update of the classification rules pushing a large number of Class I Medical Device manufacturers to involve Notified Bodies
  • Up-classification of In-Vitro Diagnostic Devices pushing a large number of Manufacturer to involve Notified Bodies in the near future
  • New clinical evaluation requirements limiting the possibilities of approval based on published clinical data
  • Increased expectations on the post-market surveillance activities for both medical devices and in-vitro diagnostic devices
  • Scrutiny process -- Influence on the approval process and time to market
  • Transparency -- New EUDAMED offering to patients, manufacturers, notified bodies and authorities

Register NOW!  Register fee $249

Event Speakers: 

  • Dr. Basil Akra, Global Director, Clinical Centre of Excellence, TÜV SÜD Product Service GmbH
  • Dr. Royth von Hahn, Vice President, Medical & Health Services, TÜV SÜD America
  • Zayna Khayat, Director, MaRS EXCITE, Senior Advisor Health Systems Innovation, MaRS Discovery District

CLICK HERE for more information or to register.

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MEDEC is the national association created by and for the Canadian medical technology industry. MEDEC is the primary source for advocacy, information and education on the medical technology industry for members, the greater healthcare community, industry partners and the general public.



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