MCRA is a leading advisory firm and Clinical Research Organization (CRO) to medical technology developers.  Core areas of expertise include regulatory, reimbursement, clinical research, healthcare compliance and quality assurance.

Consulting

MCRA

MCRA's headquarters in New York, NY, United States

The Tokyo office likely focuses on project management, business development, and regulatory affairs within the region.

Tokyo

The Manchester office focuses on reimbursement strategies and data management in clinical trials and patient access programs.

Manchester

Anonymous

Glenn Stiegman

Jason H.

Michael Anselmo

Alyssa Howard

Samuel Pollard

Hanny Hillal

This department is responsible for ensuring that products meet regulatory standards and compliance within their respective therapeutic areas.

Regulatory Affairs

The Leadership Team at MCRA is responsible for guiding the strategic direction and operational excellence of the firm. Comprising experts in regulatory affairs, clinical research, and reimbursement strategies across various medical technology domains, the team collaborates to ensure compliance, drive innovation, and enhance market access for clients. Their collective expertise enables MCRA to effectively navigate the complex landscape of healthcare regulations, ultimately supporting the development of safe and effective medical technologies.

Leadership Team

The Regulatory Affairs and Compliance team at MCRA is responsible for navigating the complex regulatory landscape for medical technology developers. They ensure that products meet all necessary regulations and compliance standards across various specialties, including anesthesia, neurology, digital health, and orthopedics. By collaborating closely with clients, the team facilitates successful product approvals and market access while maintaining adherence to healthcare laws and guidelines.

Regulatory Affairs and Compliance

This department conducts and oversees clinical research activities and ensures compliance with regulatory standards.

Clinical Research

The Clinical Development & Regulatory Affairs team at MCRA is responsible for guiding medical technology developers through the complex landscape of clinical research and regulatory compliance. This team oversees the design and implementation of clinical studies, ensures adherence to quality assurance standards, and navigates the regulatory approval processes for innovative medical devices. With expertise across various specialties, including neurology and cardiovascular, the team collaborates to support clients in achieving successful market entry and maintaining compliance in an evolving healthcare environment.

Clinical Development & Regulatory Affairs

This department oversees the planning, execution, and management of clinical trials to ensure compliance with regulatory standards and effective data collection.

MCRA

Org chart

Teams

Regulatory Affairs

Leadership Team

Regulatory Affairs and Compliance

Clinical Research

Clinical Development & Regulatory Affairs

Clinical Operations

Offices

MCRA

Org chart

Teams

Regulatory Affairs

Leadership Team

Regulatory Affairs and Compliance

Clinical Research

Clinical Development & Regulatory Affairs

Clinical Operations

Offices

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