FDA PMA Approval
Class III approval pathway for life-sustaining cardiovascular innovation.
Cardiovascular Devices
Stents, valves, PTCA Balloon catheters, and rhythm management — Class II to Class III.
How we serve Cardiovascular Devices.
The founder of our firm has supported over two decades of development of Cardiovascular Device Programs — Including Transcatheter Valves; Drug-Eluting Stent Products; PTCA Balloon Catheters Systems & Delivery System; Implantable Devices & Related Accessories. Our team understands the evidence (engineering) and data (regulatory) required to obtain clearance/approval for High-Risk Cardiovascular Technologies: Radial Compression Testing; Fatigue Analysis; Hydrodynamics Performance Testing; Biocompatibility Studies; Shelf Life Testing; Design Verification Testing; Clinical Evidence Requirements; PMA/IDE Expectations; EU MDR Classification Logic.
Our team helps Cardiovascular Teams to convert Complex Engineering Data into Defendable Regulatory Strategies; FDA Ready Submissions; Notified Body Ready Technical Documentation; Audit Ready Quality Systems.
FDA Class III PMA
IDE / Clinical Evidence Strategy
ISO 25539 Vascular Implants
ISO 5840 Heart Valves
ISO 7198 Vascular Prostheses
ASTM F2477 Radial Strength / Compression
EU MDR Rule 8
ISO 13485 / QMSR
Where we typically engage with Cardiovascular Devices clients.
Service detail
FDA 510(k) Clearance
Predicate strategy and substantial equivalence for catheter systems, accessories and cardiovascular devices.
Quality Management Systems
ISO 13485 / QMSR builds, remediations and audit-ready quality systems.
FDA QMSR Compliance
FDA quality system readiness for design controls, CAPA, supplier controls and inspection preparation.