MCRA In the News

Sep — 2023

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

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Sep — 2022

In-Vitro Diagnostic Study Site Form

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Feb — 2018

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

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Jan — 2018

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

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May — 2017

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

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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.

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A unique integrated perspective for creating the optimal product pathway

Deep Therapy Experience

Expand Your Healthcare Distribution With MCRA Global Access

A unique integrated perspective for creating the optimal product pathway

Deep Therapy Experience

Expand Your Healthcare Distribution With MCRA Global Access

MCRA In the News

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

In-Vitro Diagnostic Study Site Form

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

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

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