Your trusted CRO partner for IVD and medical device studies
Specialized in IVD & Medical Device Clinical Trials: From Study Design to Regulatory Approval
Our Services
Accelerate Market Access for Your IVD or Medical Device
At CovarsaDx, we specialize in IVD and medical device clinical trials designed to meet FDA requirements and speed time to market. With deep expertise in regulatory consulting and clinical study design, we help sponsors navigate complex De Novo, 510(k), and EUA pathways with confidence.
We collaborate closely with sponsors and clinicians to design studies grounded in disease pathophysiology, patient population data, and clinical impact—ensuring your trial is scientifically sound, regulatory-ready, and built for success.
Meet our Leadership Team
Our leadership team brings deep expertise in IVD and medical device clinical research, regulatory consulting, and quality assurance. With decades of combined experience guiding FDA submissions and global trials, CovarsaDx’s leaders are committed to accelerating innovation through customized study strategies and regulatory clarity.