MCRA’s regulatory department is
the most experienced team guiding orthopaedic 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 orthopedic 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.
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Submissions with Direct Knowledge
of FDA’s Mindset
- IDE; PMA; BLA; 510(k); 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
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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
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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.
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REGULATORY
BROCHURES
REGULATORY LEADERSHIP &
ACCOMPLISHMENTS
Vice President of Regulatory Affairs:
Glenn A. Stiegman
View Full Biography
Team
Accomplishments
LATEST REGULATORY NEWS
July 2008 - The Gray Sheet
Expectations For Artificial Disc Trials Challenge Market Hopefuls
Read More
Volume 62, Number 3, 2007
Food and Drug Law Journal
Medical Device Reporting: Issues with Class III Medical Devices
Read More
05/15/07 Orthopedics This Week
FDA Ortho Panel Recommends STAR Ankle PMA Approval –-
With Elephant in the Room
Read More
03/23/07 - Ernst & Young to Host
MCRA, LLC in Roundtable Discussion for Israeli Orthopedic Community
Read More
02/09/07 - MCRA, LLC Hires Director
Orthopedic Regulatory Affairs, Hollace Rhodes
Read More
12/01/06 - MCRA to Lead Panel at
MedTech Insight's "In Spine & Orthopedics" Meeting
Read More
11/22/06 - MCRA, LLC Names Richard
Jansen to Regulatory Affairs Staff
Read More
11/20/06 - New York Times
FDA Panel Supports Artificial Disks for Upper Spine
Read More
09/27/06 - MCRA, LLC Names Justin
P. Eggleton as Director, Spine Regulatory Affairs
Read More
09/22/06 - MCRA, LLC Unveils Services
to Worldwide Orthopedic Device Industry
Read More
01/30/06 - MCRA, LLC Names Glenn
A. Stiegman, III as Vice President
Read More
REGULATORY WHITE PAPERS
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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. |
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