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MCRA
Company Headquarters
803 7th Street Northwest
Washington, DC 20001
United States
Buyer's Guide
Related Content
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Spine/Neurology
MCRA Hires Former FDA Associate Director to Expand Neurology Franchise
Tim Marjenin was previously assistant director of the FDA's Neurostimulation Devices Neurology Team.PR Newswire 08.19.20
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MCRA Launches Call Center to Answer Virus-Related Regulatory, Clinical Trial Queries
Company is working with multiple companies seeking emergency use authorization for devices and diagnostics designed to fight pandemic.PR Newswire 03.25.20
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Turning the New EU MDR Into a Competitive Advantage
This column examines three new elements of the EU MDR that medical device manufacturers can leverage.Dan Goldstein, Associate Director, Quality Assurance, MCRA LLC 12.02.19
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Spine/Neurology
Straightening Out a Spinal Device’s De Novo Pathway
Intellirod Spine and MCRA collaborated with FDA to take the first spinal device through the de novo pathway.Sean Fenske, Editor-in-Chief 09.16.19
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Spine/Neurology
Intellirod Spine Receives First Ever Spine FDA De Novo Approval
The company received approval for its revolutionary disposable spinal rod strain sensor, the LOADPRO.Business Wire 04.02.19
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Design | Research & Development
Trial Master File: Paper or Electronic?
...Anuradha Nagulapati, Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers 02.13.19
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Data Monitoring Committees: Making DMCs Work for Your Study
...Margeaux Rogers, Senior Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 11.30.18
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Getting Started on the Right Foot: Initiating Orthopedic Clinical Trials
...Bhavana Shivakumar , Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers LLC 09.19.18
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Innovation in the 510(k) Space: A Case for Incrementalism
...Samuel Pollard, Senior Regulatory Associate, Musculoskeletal Clinical Regulatory Advisors 08.15.18
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Software & Quality
Medical Device Quality: Why Software Is More Challenging Than Hardware
...Dan Goldstein, Manager, Quality Assurance, Musculoskeletal Clinical Regulatory Advisors 03.21.18
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The Impact of U.S. Regulation on Medical Device Innovation
...Patricia Kontoudis, Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 02.12.18
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Spine/Neurology
Emerging Implant Technologies Receives FDA Multilevel Approval for 3D Printed Cervical Cage
Product has been designed according to scientific insights on ideal pore shape and size.PR Web 01.17.18
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Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel
...Dawn A. Lissy, President & Founder, Empirical 05.19.17
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Four Questions to Help You Avoid Losing a CE Mark
...Patrick Biggins, Quality Assurance & Manufacturing, Musculoskeletal Clinical Regulatory Advisers LLC 08.09.16
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