Support for a Life Cycle Measured in Decades
Cardiac rhythm and electrophysiology (EP) devices carry some of the most demanding evidence and post-market requirements in MedTech. Those obligations can run for twenty years or more after approval.
This sheet outlines how RQM+ supports manufacturers of pacemakers, defibrillators, and ablation systems from regulatory strategy through long-term post-market follow-up, with former FDA and notified body reviewers working alongside EP clinical and laboratory experts on every program.
What’s Inside
- How former FDA and notified body reviewers fluent in sensing, shock, and ablation endpoints build the regulatory path for Class III pacemakers, defibrillators, and novel ablation modalities entering PMA and CE Mark review
- How EP and ablation trials run with experienced principal investigators, key opinion leaders (KOLs), and sites, supported by clinical research associates (CRAs) trained on the implant procedure
- How Jordi Labs, our in-house, FDA-recognized laboratory, performs extractables and leachables (E&L), biocompatibility, and failure analysis on lead insulation polymers, electrode coatings, and catheter tip materials, with validated extraction protocols already in place for pulsed-field ablation (PFA) materials
- Why reimbursement and health economics strategy run alongside regulatory planning for novel ablation technologies that face payer and regulatory questions at the same time
- How RQM+ supports post-market clinical follow-up (PMCF), registries, vigilance reporting, and post-approval studies across the full device life cycle
Who This Is For
Regulatory, clinical, quality, and market access leaders at companies developing pacemakers, defibrillators, leads, or ablation systems, including teams bringing pulsed-field ablation and other novel modalities to market.
In cardiac rhythm, approval begins a commitment that lasts as long as the device does. This sheet shows how RQM+ supports every stage of it.
