News & Publications

Press Releases

MCRA Supports Bone Health Technologies with De Novo for OsteoBoost

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Apr — 2024

Case Studies

Case Study: MCRA Assists Australian Company Epiminder with FDA Breakthrough Designation for Epilepsy Monitoring Technology

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Mar — 2024

Press Releases

MCRA’s Head of Healthcare Compliance to Serve on Michigan Board of Medicine

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Mar — 2024

Case Studies

Case Study: MCRA Assists Australian Company Epiminder with FDA Breakthrough Designation for Epilepsy Monitoring Technology

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Mar — 2024

Press Releases

MCRA Announces the Hiring of FDA Statistician for Diagnostic Devices

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Feb — 2024

Press Releases

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

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Feb — 2024

Press Releases

MCRA Provides Anzu Special Acquisition Corp I with Strategic Diligence Support Leading to Envoy Medical Merger (NASDAQ: COCH)

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Jan — 2024

Press Releases

MCRA Announces the Hiring of Former FDA Leadership to Advance its Regenerative Medicine Expertise

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Nov — 2023

Press Releases

MCRA Assists Attune Medical on FDA De Novo Marketing Authorization for ensoETM™ Esophageal Thermal Regulating Device

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Oct — 2023

Webinars

FDA Cybersecurity and Software Policy Updates: Navigating the New FDA Guidance Documents for MedTech Webinar

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Sep — 2023

Press Releases

MCRA Assists Ceribell with Obtaining FDA Breakthrough Device Designation, FDA Marketing Authorization, and CMS NTAP Reimbursement for ClarityPro Device

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Sep — 2023

News

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 — 2023

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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

News & Publications

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MCRA Supports Bone Health Technologies with De Novo for OsteoBoost

Case Study: MCRA Assists Australian Company Epiminder with FDA Breakthrough Designation for Epilepsy Monitoring Technology

MCRA’s Head of Healthcare Compliance to Serve on Michigan Board of Medicine

Case Study: MCRA Assists Australian Company Epiminder with FDA Breakthrough Designation for Epilepsy Monitoring Technology

MCRA Announces the Hiring of FDA Statistician for Diagnostic Devices

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

MCRA Provides Anzu Special Acquisition Corp I with Strategic Diligence Support Leading to Envoy Medical Merger (NASDAQ: COCH)

MCRA Announces European Expansion

MCRA Announces the Hiring of New Director of Patient Access Program Operations

MCRA Announces Launch of Integrated AI & Imaging Center

MCRA Announces the Hiring of Former FDA Leadership to Advance its Regenerative Medicine Expertise

MCRA Assists Attune Medical on FDA De Novo Marketing Authorization for ensoETM™ Esophageal Thermal Regulating Device

FDA Cybersecurity and Software Policy Updates: Navigating the New FDA Guidance Documents for MedTech Webinar

MCRA Assists Ceribell with Obtaining FDA Breakthrough Device Designation, FDA Marketing Authorization, and CMS NTAP Reimbursement for ClarityPro Device

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