North American medical device manufacturers looking to expedite process for receiving Medical Device Directive CE Marking certificates, resulting in a quicker path to certification and shorter time to the European Union (EU) market, will want to learn more about a new 10-day Service Guarantee for accelerating approval and market entry.
The Medical Device Directive (MDD) defines essential quality and safety requirements for all medical devices imported, sold and used in the EU. In addition to its 10-Day Service Guarantee, TÜV Rheinland provides medical device manufacturers with a full suite of safety and regulatory solutions including FDA 510k Reviews, electrical safety testing, electromagnetic compatibility testing, environmental compliance services and analytical services. Looking to improve upon the industry standard, TÜV Rheinland, a European Notified Body for numerous European Union Directives, recently announced the new Service Guarantee for 10-day turnaround.
TÜV Rheinland’s new 10-day MDD Service Guarantee was created to provide the medical device market a faster approval process for the ultra-competitive 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,” said David Surber, Vice President, Medical Devices, 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.”