mcra
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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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Regulatory
MCRA CRO Assists Simplify Medical, Inc. on the Fastest Spine PMA Ever Approved by the FDA
WASHINGTON, Oct. 1, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory firm and Clinical Research Organization (CRO) integrating U.S.…
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Financial
MCRA Strengthens its Reimbursement, Health Economics, and Market Access Division with the Hiring of Tess Wong, MS
WASHINGTON, Jan. 16, 2020 /PRNewswire/ — MCRA, LLC, is a leading clinical research organization (CRO) and advisory firm specializing in medical devices and…
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Recon
THINK Surgical and MCRA Announce 510(k) Clearance and US Launch of Revolutionary Total Knee Replacement Technology
WASHINGTON, Nov. 21, 2019 /PRNewswire/ — MCRA, LLC (www.mcra.com) is pleased to announce that its client THINK Surgical, Inc. has obtained clearance…
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Biologics
Ortho Regenerative Technologies selects US based specialized CRO, MCRA LLC, for its upcoming phase I/II rotator cuff human trial
MONTREAL, Sept. 12, 2019 /CNW/ – Ortho Regenerative Technologies Inc. (CSE: ORTH) (“Ortho RTI” or the “Company“), an emerging Orthobiologics company, announced today…
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Financial
MCRA Hires Reimbursement Leader Tonya N. Dowd, MPH, as Vice President of Reimbursement, Health Economics, and Market Access
WASHINGTON, August 22, 2019 /PRNewswire/ — MCRA, LLC (www.mcra.com), a leading medical device advisory firm and Clinical Research Organization (CRO)…
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Regulatory
Intellirod Spine Receives First-Ever Spine FDA De Novo Approval
April 01, 2019 AKRON, Ohio–(BUSINESS WIRE)–Intellirod Spine, the spinal sensor technology company developing wearable, disposable and implantable wireless sensors for…
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