Case Studies

Case Study: MCRA Assists Empirical Spine with Pre-Market Approval of Breakthrough Device, LimiFlex Dynamic Sagittal Tether

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Case Study: MCRA Assists PROCEPT BioRobotics in Establishing Regulatory Approval and Reimbursement Listing in Japan

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Case Study: MCRA Plays Significant Role in Securing PMA Approval for Companion Spine’s DIAM™ Spinal Stabilization System

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Case Study: MCRA Assists KeriMedical SA with Pre-Market Authorization Approval of Breakthrough Device, TOUCH® CMC1 Prosthesis

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Case Study: Fasikl Receives FDA Clearance for Felix NeuroAI™ Wristband, the First and Only AI-Powered Treatment for Essential Tremor

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Case Study: MCRA Assists ReGelTec with IDE Approval for HYDRAFIL, the First Pivotal US Clinical Trial Approved for Nucleus Pulposus Augmentation

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Case Study: MCRA Assists Evaheart’s Pivotal COMPETENCE Trial in Support of the EVAHEART®2 LVAS

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Case Study: MCRA’s Regulatory and Reimbursement Team Helped Move icotec Through Commercialization

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Case Study: MCRA Helps Rescue a Clinical Study That Previous CRO Mismanaged

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

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

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

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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.