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Home » New Product Gives Medical Device Manufacturers a More Efficient and Cost-Effective Road to Certification

New Product Gives Medical Device Manufacturers a More Efficient and Cost-Effective Road to Certification

May 9, 2012 By MassDevice Contributors Network

(Kensington, MD) – Medical device manufacturers can now secure a decision on CE Marking certification and ISO 13485 under CMDCAS certification in as little as 30 days through a new program offered by a leading notified body. G-MED North America’s new ExpressCert program offers clients a choice of expedited reviews. Under the ExpressCert program, medical device manufacturers can receive an assessment for their device in 30 days.

“Our certification timeframe is already very efficient,” explains Marketing Coordinator and Regulatory Affairs Specialist Sarah Stec. “While our company always strives to exceed client expectations, we decided to announce ExpressCert so that manufacturers are aware that reasonable and faster speed is available for their needs and their devices.”

As one of the first notified bodies to cover the medical device directives, LNE/G-MED, and its North American subsidiary, G-MED North America, developed significant efficiencies by applying its over 30 years of experience. These efficiencies created ideas and products such as multiple assessments (e.g. CE Mark, ISO 13485, CMDCAS, etc.) in a single audit, dedicated U.S.-based project managers, and on-site sampling of tech-files (for lower-risk products) during the audit.

Medical device manufacturers can take advantage of G-MED North America’s extensive expertise while receiving a more efficient committee decision, and trust that G-MED North America still has the best value. While a nominal fee applies to the ExpressCert program, it is still an excellent value for a medical device manufacturer.

Some devices (e.g. those involving animal products, blood derivatives, highly innovative devices, etc.) are naturally excluded, this program covers products in all risk classes, as well as In Vitro Diagnostic (IVD) Devices. Manufacturers can contact G-MED North America for a customized certification timeframe and to determine which program best suits their needs.

Contact: John Vaccaro, Account Manager, G-MED North America, (301) 495-0477. For more information on ExpressCert, visit our website.

About G-MED North America
The North American subsidiary to LNE/G-MED, one of Europe’s leading Notified Bodies, G-MED North America serves clients with local auditors and project teams, while also offering training and testing services to medical device manufacturers.

Filed Under: Uncategorized

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