Evidence Built for Long Follow-Up Windows
Structural heart and mechanical circulatory support (MCS) programs depend on rigorous evidence, independent review, and follow-up windows that often run five to 10 years. The regulatory, clinical, laboratory, and reimbursement plan must account for all of it from the first protocol.
This sheet outlines how RQM+ supports manufacturers of transcatheter and surgical valves, occluders, and circulatory assist devices, combining former FDA and notified body experience with specialized structural heart clinical trial and materials capability.
What’s Inside
- How former FDA and notified body reviewers build the U.S. and EU path for novel, no-precedent transcatheter aortic and mitral valve (TAVR and TMVR) devices and complex Class III premarket approval (PMA) submissions
- How structural heart studies are designed around independent event adjudication and echo and computed tomography (CT) core lab review, with committees operating strictly to charter and imaging review standardized and blinded
- How Jordi Labs, our in-house, FDA-recognized laboratory, provides bioprosthetic-tissue chemistry, including glutaraldehyde residual quantitation and biological material identification, alongside synthetic materials characterization for occluders and assist devices
- How Lumo™, our AI materials science platform, flags biocompatibility and extractables and leachables (E&L) risks early
- Why reimbursement and health economics planning is built to match the multiyear durability evidence these devices generate
Who This Is For
Regulatory, clinical, quality, and market access leaders at companies developing transcatheter or surgical valves, occluders, or circulatory assist devices, from early development through post-approval studies.
Durability evidence takes years to earn, and the plan to earn it starts with the first protocol. This sheet shows how RQM+ supports that plan end to end.
