MCRA US FDA Neuro-Musculoskeletal Regulatory Services

  


MCRA’s regulatory department is the most experienced team guiding musculoskeletal technologies through FDA approval at any point of the device life-cycle: from pre-clinical testing, to FDA submission, to market approval, and post commercialization.

MCRA combines vast neuro-musculoskeletal industry knowledge with nearly 30 years of FDA experience. The result is that MCRA leverages data generated through mechanical, animal, or clinical testing, with unrivaled competitive knowledge, making MCRA the most experienced team to advise or execute the regulatory pathway of your musculoskeletal technology.

MCRA’s team will save your company both time and money, while creating optimal value for your technology.

CORE REGULATORY SERVICES
 
 

Submissions with Direct Knowledge of FDA's Mindset

  • 510(k), IDE, PMA, IND, BLA, HDE
  • Pre-IDE/BLA, Day 100, & Panel Meetings

Strategy, Analysis & Development

  • Predicate Landscape & Device Design
  • Balancing Indications, Costs & Claims
  • Leveraging Regulations, Competition New Opportunities

Design, Review & Implement Pre-Clinical Testing

  • Mechanical, Biocompatibility, Biomechanical & Animal

Other Services

  • Annual Updates for PMA, BLA & HDE Devices;
  • New Product Acquisitions & Transfer of Ownership;
  • Adverse Event Reporting
  • Site Registrations;
  • Device Listing;
  • US Agent for Foreign Companies
 
INTEGRATION WITH MCRA'S OTHER DIVISIONS
 
 

Clinical

  • Customized Clinical Study Design
  • Innovative & Unique Clinical Protocols
  • IRB Approvals

Reimbursement

  • Recommend Regulatory Pathway Based on Current Coding & Client’s Financial Resources
  • Healthcare Economic Data Included Within Regulatory Submissions for Future Coding Purpose

Intellectual Property

  • Redesigns & Improvement of Implants & Instrumentation


The true value of MCRA is the integration of 5 business value creators – orthopedic regulatory, reimbursement, clinical, intellectual property and quality assurance. MCRA places particular emphasis on working with companies at all stages of development, whether they are single-product companies or companies with several thousand technologies.

REGULATORY BROCHURES






REGULATORY LEADERSHIP & ACCOMPLISHMENTS

Vice President of Regulatory Affairs:
Glenn A. Stiegman
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Vice President of Biologics:
James T. Ryaby, PhD
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Team Accomplishments


LATEST REGULATORY NEWS & PUBLICATIONS

January 2012 - Seminars in Spine Surgery
Regulatory Challenges in Getting Total Disc Replacements Onto the Market in an Era of Increased Food and Drug Administration Scrutiny
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July 2008 - The Gray Sheet
Expectations For Artificial Disc Trials Challenge Market Hopefuls
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Volume 62, Number 3, 2007
Food and Drug Law Journal
Medical Device Reporting: Issues with Class III Medical Devices
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05/15/07 Orthopedics This Week
FDA Ortho Panel Recommends STAR Ankle PMA Approval –- With Elephant in the Room
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03/23/07 - Ernst & Young to Host MCRA, LLC in Roundtable Discussion for Israeli Orthopedic Community
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02/09/07 - MCRA, LLC Hires Director Orthopedic Regulatory Affairs, Hollace Rhodes
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12/01/06 - MCRA to Lead Panel at MedTech Insight's "In Spine & Orthopedics" Meeting
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11/22/06 - MCRA, LLC Names Richard Jansen to Regulatory Affairs Staff
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11/20/06 - New York Times
FDA Panel Supports Artificial Disks for Upper Spine
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09/27/06 - MCRA, LLC Names Justin P. Eggleton as Director, Spine Regulatory Affairs
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09/22/06 - MCRA, LLC Unveils Services to Worldwide Orthopedic Device Industry
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01/30/06 - MCRA, LLC Names Glenn A. Stiegman, III as Vice President
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REGULATORY WHITE PAPERS


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Phone: 202.552.5800
Fax: 202.552.5798
Email: info@mcra.com
 
 
Musculoskeletal Clinical Regulatory Advisers, LLC is the leading neuro-musculoskeletal / orthopaedic consulting firm assisting established and emerging companies in the development and commercialization of their technologies. MCRA’s consultants are industry leaders who support Clinical, Regulatory, Quality Assurance, Reimbursement, Intellectual Property, and Healthcare Compliance initiatives. MCRA’s integration of these key value creating initiatives, as well as its focused specialization, creates unparalleled expertise to its clientele.