OUR SERVICES
 
US FDA REGULATORY
 
 

• FDA Submissions (510(k), IDE, PMA, IND, BLA, HDE)

• International Regulatory Affairs

• Strategy Analysis & Development

• Predicate Landscape & Device Design

• Design, Review & Implement Pre-Clinical Testing

SEE COMPLETE REGULATORY OFFERINGS

 
 
HEALTH ECONOMICS,
REIMBURSEMENT & PUBLIC POLICY
 
 

• Strategic Reimbursement Planning

• Reimbursement Landscape Assessments

• Coding & Add-On Payment Development & Applications

• Healthcare Policy Development & Advocacy

• Utilization Analysis

• Predictive Economic Utilization Modeling

• Clinical Trial Reimbursement Planning

SEE COMPLETE REIMBURSEMENT OFFERINGS

 
 
QUALITY ASSURANCE
& INTERNATIONAL REGULATORY
 
 

• Quality System Creation, Modification & Implementation

• Pre-PMA Auditing

• Personnel Training
- MDD
- QSR
- ISO 13485
- Risk Management

• Prospective & Retrospective Validation

SEE COMPLETE QUALITY ASSURANCE OFFERINGS

 
 
CLINICAL
 
 

• Retrospective & Prospective Study Management

• Literature Searches & Analysis

• “Ghostwriting” for Publications & Presentations

• Case Report Form (CRF) Development

• Study Proposal & Budget Development

SEE COMPLETE CLINICAL OFFERINGS

 
 
INTELLECTUAL PROPERTY
 
 

• Clearance Analyses

• Patentability Searches

• Invalidity Searches

• Competitive Patent Landscapes

• Product or Technology Due Diligence

SEE COMPLETE IP OFFERINGS

 
 
SURGEON ETHICS & COMPLIANCE
 
 

• Compliance Program Establishment, Implementation, & Monitoring

• Compliance Auditing

• Contract and Financial Activity Review

• Investigation of Inappropriate Activities

• Compliance Hotline Management

SEE COMPLETE SURGEON ETHICS & COMPLIANCE OFFERINGS

 
MANAGEMENT BROCHURE
 
 
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.