Our Service Offerings

Our team has built an established reputation by working to streamline the effectiveness and success of clinical trials for over a decade.

MCRA is the leading U.S. Regulatory Advisor for the Medical Device and Biologics industries. Our deep bench of talent in virtually every discipline creates value and mitigates risk by combining  unparalleled comprehension of FDA laws and regulations. MCRA both advises and implements all types of strategies and FDA submissions.

Our expansive experience with international regulatory bodies across a number of device technologies enables us to help clients operate, expand, and achieve long-term business objectives in global markets.

Today, reimbursement is the most complex and significantly changing dynamic in healthcare technology commercialization.

We understand that medical device companies must adhere to strict FDA and international quality assurance requirements to ensure product consistency and safety.

An effective healthcare compliance program is a fundamental business requirement for any healthcare organization.