Case Studies

Empowering FDA Clearance of United Imaging Intelligence Technology in Under 60 Days

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MCRA Assists Pangea Laboratory to Achieve Breakthrough Device Designation

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MCRA Assists Epiminder with FDA De Novo Approval for Minder, the First Implantable, Continuous EEG Monitor for Epilepsy

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MCRA Leads the Way: Empowering Synergy Spine Solutions with Comprehensive Regulatory, Clinical, and Healthcare Compliance Solutions Worldwide

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MCRA Assists SANUWAVE with Successful De Novo Decision for only the 3rd Wound Care De Novo Approved between 2010-2018

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MCRA Supports BONESUPPORT with FDA De Novo Clearance and Reimbursement Strategy for CERAMENT G

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MCRA Supports CamDiab with FDA Approval for Artificial Pancreas Software

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MCRA Supports Darmiyan with FDA Approval for BrainSee Device

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MCRA Assists Occlutech through Sunshine Act Compliance and Clinical Monitoring Support

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MCRA Supports 3D Systems with 510(k) FDA Clearance for VSP PEEK Cranial Implant Device

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MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System

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MCRA Supports Onkos Surgical with First FDA De Novo Approval for Antibacterial Coating for Implants

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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.