Responsible for the management of MCRA, LLC., the leading specialized advisory and consulting firm exclusively servicing the orthopedic industry in the key areas of regulatory, clinical, reimbursement, intellectual property, quality assurance, manufacturing, and healthcare compliance.
Manages more than 40 employees and is responsible for the financial, operational and strategic directives of the firm.
Ms. Rhodes is responsible for regulatory affairs relevant to general orthopedic devices (hip, knee, small bone, trauma, etc.) for MCRA's clients, assisting clients with writing regulatory submissions, identifying the appropriate regulatory pathway for new technologies and indications, developing regulatory, clinical, and testing strategies for new devices, and assisting clients with response and appeal strategies for 510(k), IDE, PMA, and de novo submissions.
Mr. Eggleton is responsible for regulatory affairs relevant to the spine devices for MCRA clients, with experience writing FDA submissions and drafting test protocols. He also develops regulatory strategies for unique indications, device designs, or materials.
The FDA requires proof of compliance with established design control procedures during the product design and development phase.
MCRA's world class know-how and execution unlocks barriers, advancing our clients mission to better the availability of quality medical care to patients around the world.