Case Studies

Aug — 2025

Case Study: MCRA Assists Pangea Laboratory to Achieve Breakthrough Device Designation

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Jul — 2025

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

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Jul — 2025

Case Study: MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with OstaguardTM Coating

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Jul — 2025

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

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May — 2025

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

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Apr — 2025

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

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Apr — 2025

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

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Apr — 2025

Case Study: MCRA Supports CamDiab with FDA Approval for Artificial Pancreas Software

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Mar — 2025

Case Study: MCRA Supports Darmiyan with FDA Approval for BrainSee Device

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Mar — 2025

Case Study: MCRA Assists Occlutech through Sunshine Act Compliance and Clinical Monitoring Support

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Feb — 2025

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

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Jan — 2025

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

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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

Case Studies

Case Study: MCRA Assists Pangea Laboratory to Achieve Breakthrough Device Designation

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

Case Study: MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with OstaguardTM Coating

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

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

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

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

Case Study: MCRA Supports CamDiab with FDA Approval for Artificial Pancreas Software

Case Study: MCRA Supports Darmiyan with FDA Approval for BrainSee Device

Case Study: MCRA Assists Occlutech through Sunshine Act Compliance and Clinical Monitoring Support

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

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