VISION is to be the globally dominant and most successful musculoskeletal
regulatory, clinical, intellectual property, and reimbursement
strategists, helping musculoskeletal companies achieve maximum
value for all stakeholders.
Our MISSION is to use the most experienced
musculoskeletal strategic advisory team to guide your orthopedic products
through the regulatory, clinical, intellectual property, and reimbursement
process quickly and successfully, thereby creating maximum value for
Our LEADERSHIP has extensive experience
and success in bringing Class II and III Medical Devices to market.
Our regulatory team has reviewed over 1,000 regulatory submissions.
The clinical team has written, advised and/or monitored approximately
100 various studies for the orthopedic market. Our intellectual property
expertise includes the examination, drafting, prosecution and pre-litigation
preparation of over 220 issued orthopedic-specific patents and/or patent
applications. The reimbursement department has led over 1,200 healthcare
Our VALUES are centered around placing
the patient’s needs first, ensuring thorough and diligent analysis
of all of your needs, and providing uncompromising “first-in-class”
service that is uniquely differentiated and results in maximum value
for all of your stakeholders.
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 orthopedic Clinical, orthopedic Regulatory, orthopedic Quality Assurance, orthopedic Reimbursement,orthopedic surgeon and corporate ethics and compliance and orthopedic Intellectual Property initiatives. MCRA’s integration of these key value creating initiatives, as well as its focused specialization, creates unparalleled expertise to its clientele.