With many years of industry experience in the research and development of percutaneous and surgical heart valve products, we have supported successful regulatory submissions for both very large and very small companies seeking to initiate clinical trials for heart valve devices.
Our capabilities include all hydrodynamic testing required by the FDA and ISO 5840 as well as design specific testing and troubleshooting of novel devices.
In addition, MC3 is actively involved in concept development, design, prototyping, and testing of shape memory devices and delivery systems for percutaneous valve repair.