MCRA is the preeminent team, assisting
orthopaedic companies in achieving regulatory and standard compliance
with U.S., European and Canadian agencies and organizations. MCRA’s
integration of services allows us to coordinate U.S. and international
regulatory strategies to streamline the commercialization and validation
processes.
It is imperative that orthopedic companies
understand the various nuances of U.S. quality system requirements
versus those of Europe and other countries. A proper quality system
is often overlooked by small companies and deemed cumbersome, but
is critical for commercialization. Larger companies, on the other
hand, could benefit from MCRA’s services to streamline procedures
and improve efficiencies.
MCRA’s assistance in quality
assurance and international regulatory affairs is just one of our
service components necessary on the road to commercialization for
musculoskeletal companies.
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Quality System Creation/Modification/Implementation
- Compliance Assessment
- FDA QSR, ISO 13485, European Medical
Device Directive; Canadian Medical Device Regulation
- Create Quality Manual; Standard Operating
- Uniform Approach for US & International
Strategy Procedures; Work Instructions
- Internal & Supplier Quality Audits
- Reports from International Submissions
International Regulatory Affairs
- CE Mark Approval
- Create or Update Technical Files
- Design Dossiers Obtain & Maintain
Device Licenses
- Obtain & Maintain Device Licenses
Personnel Training
- MDD, QSR, ISO 13485, Risk Management
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Intellectual Property
- Design Control Process
- Labeling Development
Regulatory
- Uniform Approach for US & International
Strategy
- Consolidated Testing Strategy
- Internal & Supplier Quality Audits
Reports from International Submissions Utilized for US Submissions
- Design Controls to Meet FDA Requirements
& Use in FDA Submissions
Clinical
- Clinical Paper Demonstrating Equivalence
Based on Literature Search
- Approval with Competent Authority
& Local Law
- Adherence to Harmonized Standards,
Helsinki Accords, & Patient Privacy
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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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QUALITY
ASSURANCE BROCHURES
QUALITY ASSURANCE LEADERSHIP &
ACCOMPLISHMENTS
Vice President, Quality Assurance and International Regulatory:
Kevin Ladd
View Full Biography
Team Accomplishments
LATEST QUALITY ASSURANCE NEWS
02/09/07 - MCRA Unveils New Business
Unit for Quality Assurance and International Regulatory Affairs
Read More
QUALITY ASSURANCE WHITE PAPERS
View Text
View PDF
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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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