Overview

MCRA's world class team and >100 integrated services allows for us to be the #1 partner to assist you in unlocking value.

Clinical Research Organization (CRO)

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

MCRA has been streamlining the effectiveness and success of clinical trials for nearly a decade, advising across every stage of the process – from site qualification to post commercialization.

US Regulatory

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.

We provide our clients with the best FDA representation in demonstrating the science, safety, and efficacy of their technologies.

International Regulatory

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.

MCRA's comprehensive and integrated international regulatory services are designed to support your device throughout the entire product lifecycle, and help you reach international markets.

Reimbursement, Health Economics & Market Access

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

MCRA’s reimbursement experts guide leading healthcare companies through the most complex dynamic in medical technology commercialization today.

Quality Assurance

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

Our quality assurance team combines their in-depth knowledge to cover the nuances of this complex area.

Healthcare Compliance

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

MCRAs Compliance Services are designed to support the growing healthcare organization or medical device company that knows an effective Corporate Compliance Program is an essential business requirement in today's complex legal and regulatory environment.

Cybersecurity

Are your medical devices secure? With the continued advancement in technology and medical devices, MCRA's cybersecurity experts provide full integrated services to secure and protect your medical device by leading the discussions and delivering thorough risk assessments, strategy, and advisory services.