Peabody, MA. TÜV SÜD America’s Roadshow events, entitled “Influence of the new regulations on the CE Marking Approval in Europe” will take place in six different cities across the U.S. and Canada from August 2-August 11, 2016.
The Roadshows are live, half-day trainings and include technical presentations, questions and answer sessions and networking with TÜV SÜD Medical experts, Dr. Bassil Akra and Dr. Royth von Hahn.
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
- Updates on 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 access to patients, manufacturers, notified bodies and authorities
For more information on training locations, or to register visit www.tuv-sud-america.com/MHSroadshows. Seating is limited.
For more information on TÜV SÜD’s Medical and Health Services full offerings, go to www.tuv-sud-america.com/Medical.
- Lisa Van Dorpe
- Brand and Marketing Associate
- TÜV SÜD America
- Phone: (978) 573-2513
About TÜV SÜD
The year 2016 marks the 150th anniversary of TÜV SÜD – a premium quality, safety, and sustainability solutions provider that specialises in testing, inspection, auditing, certification, training, and knowledge services. Since 1866, the company has remained committed to its founding principle of protecting people, property and the environment from technology-related risks. Headquartered in Munich, Germany, TÜV SÜD is represented in more than 800 locations worldwide. TÜV SÜD operates globally with a team of more than 22,000 multi-disciplinary experts recognised as specialists in their respective fields. By combining impartial expertise with invaluable insights, the company adds tangible value to businesses, consumers and the environment. The aim of TÜV SÜD is to support customers with a comprehensive suite of services worldwide to increase efficiency, reduce costs and manage risk. Today, it continues to play a pivotal role as a future-oriented company shaping industry “next practice”.