mcra
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Biologics
MCRA Supports Onkos Surgical with First FDA De Novo Approval for Antibacterial Coating for Implants
WASHINGTON, June 20, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory…
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Spine
MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with Ostaguard™ Coating
MCRA Responsible for Regulatory Strategy and Support for FDA Submission Process WASHINGTON, May 7, 2024 /PRNewswire/ — MCRA, the leading privately held…
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Spine
MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System
WASHINGTON, Feb. 20, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and…
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Regulatory
MCRA Announces European Expansion
WASHINGTON, Jan. 10, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and…
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Regulatory
MCRA Announces Launch of Integrated AI & Imaging Center
Led by Former FDA Imaging Experts MCRA AI & Imaging Center is the first and only integrated solution covering Medical…
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Biologics
MCRA Announces the Hiring of Former FDA Leadership to Advance its Regenerative Medicine Expertise
WASHINGTON, Nov. 15, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics focused clinical research organization (CRO) and advisory firm…
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Regulatory
MCRA Announces New Vice President of Reimbursement, Healthcare Economics, and Market Access
WASHINGTON, Dec. 8, 2022 /PRNewswire/ — MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating…
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Regulatory
MCRA Expands Recently Formed Biocompatibility Division with 2 Key Hires from FDA and Industry
As regulatory scrutiny over device biocompatibility increases, MCRA forms a world class team of biocompatibility experts from FDA and industry.Key…
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Spine
3Spine, Inc. Announces IDE Approval
CHATTANOOGA, Tenn., June 22, 2022 /PRNewswire/ — 3Spine, Inc., a medical device company developing total joint replacement for the lumbar spine, today…
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Biologics
MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA
CERAMENT G is the first combination product which has successfully navigated the DeNovo process.To date, MCRA has supported 5 of…
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Regulatory
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’s CRO and Regulatory Teams assisted Active Life Scientific, Inc. with integrated regulatory and clinical research services to support…
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Biologics
MCRA Expands International Regulatory Team
Peter Bowness, Ph.D., former British Standard Institution (BSI) senior regulator and decision maker joins MCRA as Director, International Regulatory Affairs…
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Regulatory
MCRA Hires Melissa Paper, JD, MPA, CHC as Vice President of Healthcare Compliance
– Melissa Paper, JD, MPA, CHC joins MCRA as Vice President of Healthcare Compliance WASHINGTON, Oct. 21, 2021 /PRNewswire/ — MCRA, LLC,…
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Regulatory
MCRA CRO Assists Simplify Medical, Recently Acquired by NuVasive, on FDA-Approval for Two Level use of its Cervical Disc
– MCRA’s CRO assisted Simplify Medical, Inc. (Simplify Medical) with the conduct, execution and oversight of the clinical study, including…
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Neuro
MCRA Hires Former Leader of FDA Breakthrough Device Program & Neurology Division Manager
WASHINGTON, Oct. 8, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating…
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