News & Publications

Publications

MCRA Expands Recently Formed Biocompatibility Division with 2 Key Hires from FDA and Industry

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Aug — 2022

Press Releases

MCRA Assists NeuroMetrix with Obtaining FDA Breakthrough Device Designation and Marketing Authorization in One Year

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Jul — 2022

Publications

Compliance Flash: Physician Owned Distributorship

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Jul — 2022

Press Releases

MCRA and Clients Achieve Significant Milestone - Over 60 Breakthrough Device Designations Granted by FDA

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Jun — 2022

Press Releases

MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA

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Jun — 2022

Press Releases

MCRA Assists Net Health in Receiving Breakthrough Device Status

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Jun — 2022

Publications

Compliance Flash: Single Use Devices

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Jun — 2022

Press Releases

MCRA Acquires Vorpal Technologies K.K. to Further Expand its Global Advisory Services in Japan

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Mar — 2022

Publications

Risk Management is critical to establishing a positive benefit: risk profile and ensuring the best possible patient outcomes. By: Peter Bowness Director, International Regulatory Affairs

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Jan — 2022

Press Releases

MCRA Assists Active Life Scientific with Clinical Study Execution and Successful De Novo Decision for the OsteoProbe - A New Tool to Measure Bone Tissue

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Jan — 2022

Press Releases

MCRA Assists Multiple Clients with Successfully Obtaining CPT Codes and Hospital Payment Reassignments

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Jan — 2022

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Compliance Flash: Cyber Criminals Target Healthcare

MCRA Overview: 2022 FDA Draft Guidance

In-Vitro Diagnostic Study Site Form

Video: Navigating the Global IVD Landscape

Compliance Flash: Sunshine Act and Open Payments

MCRA Expands Recently Formed Biocompatibility Division with 2 Key Hires from FDA and Industry

MCRA Assists NeuroMetrix with Obtaining FDA Breakthrough Device Designation and Marketing Authorization in One Year

Compliance Flash: Physician Owned Distributorship

MCRA and Clients Achieve Significant Milestone - Over 60 Breakthrough Device Designations Granted by FDA

MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA

MCRA Assists Net Health in Receiving Breakthrough Device Status

Compliance Flash: Single Use Devices

MCRA Acquires Vorpal Technologies K.K. to Further Expand its Global Advisory Services in Japan

Risk Management is critical to establishing a positive benefit: risk profile and ensuring the best possible patient outcomes. By: Peter Bowness Director, International Regulatory Affairs

MCRA Assists Active Life Scientific with Clinical Study Execution and Successful De Novo Decision for the OsteoProbe - A New Tool to Measure Bone Tissue

MCRA Assists Multiple Clients with Successfully Obtaining CPT Codes and Hospital Payment Reassignments

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