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TÜV Rheinland of North America

FDA Compliance

Medical Devices Can Get to the EU Market Faster with TÜV Rheinland

European notified body expedites process for receiving Medical Device Directive CE marking certificates

Published: Friday, October 15, 2010 - 13:58

(TUV Rheinland of North America: Newtown, CT) -- TÜV Rheinland, a European notified body for numerous European Union (EU) directives, announced a new service guarantee for 10-day turnaround of CE marking certificates for the Medical Device Directive (MDD) of the European Union (EU). Setting a new standard for the industry, TÜV Rheinland offers North American medical device manufacturers an expedited process for receiving MDD CE marking certificates, resulting in a quicker path to certification and shorter time to the EU market.

TÜV Rheinland’s new 10-Day Service Guarantee was created to provide the medical device market a faster approval process for the ultracompetitive EU market. With ongoing process improvements, dedicated resources, and improved communication tools, manufacturers are provided with a transparent certification timetable from the beginning of the auditing process, bringing predictability, and control to their product launch schedules.

“We are committed to continually developing new and innovative processes to get our customers products to market faster,” says David Surber, vice president of medical devices at TÜV Rheinland. “With our 10-day certification process, our customers will benefit from our market leading process, providing them with their MDD certificates faster than ever before.”

The MDD defines essential quality and safety requirements for all medical devices imported, sold, and used in the EU. In addition to its 10-DayService Guarantee, TÜV Rheinland provides medical device manufacturers with a full suite of safety and regulatory solutions including FDA 510(k) reviews, electrical safety testing, electromagnetic compatibility testing, environmental compliance services, and analytical services.

To learn more about TÜV Rheinland’s 10-Day Service Guarantee program and other medical industry services, visit www.tuv.com.

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TÜV Rheinland of North America

TÜV Rheinland of North America observes and assures innovations are in harmony with humanity, technology and the environment. As an international service group, TÜV Rheinland of North America documents the safety and quality of new and existing products, systems, and services. Its interdisciplinary competence is neutral and independent. TÜV Rheinland of North America orients itself to relevant standards and meaningful performance measures, and it participates in developing these worldwide.