Our Experience in In-Vitro Diagnostic Devices

Our mission is to provide best-in-class regulatory, clinical, and reimbursement services to help IVD companies achieve their product development and commercialization goals. We have structured our approach to navigating the regulatory, clinical and commercial landscape to align with the focus on the Total Product Life Cycle, a regulatory framework that integrates all aspects of product development and post-market surveillance. The battery of services in MCRA’s IVD portfolio enables us to partner with our clients through the various stages of the innovation process: from design, through pre-market development and market approval, to reimbursement. As an experienced IVD consultancy, MCRA is capable of taking on projects of any complexity, in diverse product areas. This includes ensuring compliance with US agencies, the EU’s IVD Regulation (IVDR) and others.

MCRA’s team offer a range of services for IVDs, including: Clinical partnerships for running clinical studies, clinical performance study protocol reviews, site set-up and monitoring, through to close-out activities; and Regulatory support for US/Europe submissions, global registrations, regulatory development strategies, or EU IVDR Annex XIV submissions to EU Competent Authorities, and insight of regional regulations for conducting clinical studies.

Our IVD and IVDR consulting firm is able to work hand-in-hand with IVD device manufacturers, or Pharmaceutical partners for CDx devices, to support them through their clinical studies and regulatory strategy to market approval. MCRA believes that having an expert IVD or IVDR consultant on your side to help guide key decisions at all stages is a differentiator for successful projects.

For further information on our IVD and IVDR consultancy services, please follow the below links:

Contact an IVD Expert

Our Team

View Contact
James Mullally, Ph.D.

James Mullally, Ph.D.

Vice President, In-Vitro Diagnostic Regulatory Affairs
View Contact
Erica Conway, Ph.D.

Erica Conway, Ph.D.

Vice President, IVD Regulatory Affairs - Europe
View Contact
Julie Martel, Ph.D.

Julie Martel, Ph.D.

Vice President, IVD Clinical Affairs