MCRA IVD has decades of combined in-vitro diagnostics (IVD) experience, including direct oversight of IVD regulation from former FDA and Notified Body personnel, as well as IVD clinical study execution. Our IVD consulting services extend from the US, Europe and further global markets, spanning the breadth of IVD intended uses, including Companion Diagnostics (CDx).
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:
In-Vitro Diagnostic Devices Clinical Research Organization (CRO)
Our proven expertise, and dedicated team of Directors, Clinical Team Managers, In-House and Field Clinical Research Associates ensure our clients the support they need to generate the clinical data required for successful regulatory agencies approval, and devices commercialization.
In-Vitro Diagnostic Devices US Regulatory
We have the experience and know-how to ensure your technology is successfully guided through the complex and challenging FDA regulatory process.
In-Vitro Diagnostic Devices Global Regulatory
With the help of our strong regulatory and scientific leadership, our clients experience little difficulty when bringing their devices to new markets around the world.
In-Vitro Diagnostic Devices Reimbursement, Health Economics, and Market Access
We have more than 50 years of experience when it comes to reimbursement, health economics, and public policy services, making us your full-service resource in every regard.
In-Vitro Diagnostic Devices Quality Assurance
Our clients depend on us to manage all their document control, R&D, risk management, software development, supplier evaluation, measurement equipment control, and other processes.
In-Vitro Diagnostic Devices Healthcare Compliance
We deliver comprehensive know-how when it comes to navigating the most complicated legal representation and GDPR our clients have to face.
In-Vitro Diagnostic Devices Cybersecurity
Advanced technology in the medical sector needs to be protected against cybercrime and data breaches, and our experience provides these critical services for organizations.