MCRA In the News

Update to FDA Guidance Use of International Standard ISO 10993-1 and Biocompatibility of Devices in Contact with Intact Skin

By: Claus Soendergaard, Senior Manager of Biocompatibi

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In-Vitro Diagnostic Study Site Form

IVD Study Site Pamphlet

The Impact of U.S. Regulation on Medical Device Innovation

Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators.

Sanuwave Receives FDA De Novo Decision to Immediately Market the Dermapace System for the Treatment of Diabetic Foot Ulcers in the U.S.

SUWANEE, GA, Jan. 02, 2018 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCQB: SNWV) has announced that the U.S.

Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

For a company navigating a Class III medical device’s path to market, the U.S.

The Journey Is Long, Pick The Right Partner

MCRA's world class know-how and execution unlocks barriers, advancing our clients mission to better the availability of quality medical care to patients around the world.