Our Service Offerings

Overview

MCRA's world class team and >100 integrated services allows for us to be the #1 partner to assist you in unlocking value. Since 2004, MCRA’s team has led many of the industry's most important projects and has been at the forefront of many changing dynamics affecting medical devices and biologics.

Global Medical Device Clinical Research Organization (CRO)

MCRA has been streamlining the effectiveness and success of clinical trials for nearly 20 years, advising across every stage of the process - from site qualification to post commercialization.

FDA Regulatory Consultant For Medical Devices

As FDA regulatory consultants, we provide our clients with the best representation in demonstrating the science, safety, and efficacy of their technologies.

Global Regulatory

Our expansive regulatory affairs experience in the United States, European Union, United Kingdom, Japan, Canada and other international countries across medical device therapies enables us to help clients achieve long-term business objectives and expand into other global markets.

MCRA's comprehensive and integrated global regulatory medtech services are designed to support your product throughout the entire product lifecycle, expediting successful market access and commercialization.

Medical Device Reimbursement Consultants

MCRA’s medical device reimbursement consultants 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 global 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 Solutions For Medical Devices

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