- Materials and Processes
With comprehensive manufacturing capabilities, we develop cardiovascular catheters in a wide range of models and configurations. Our technical experts ensure the highest-quality materials are matched to the precise design specifications and requirements of every cardiovascular component and cardiovascular device we manufacture.
We maintain ISO 13485 certification across our facilities, as well as quality and process management systems that meet the highest standards set by the United States Food and Drug Administration, the European Community, and other international regulatory authorities. Our technical experts ensure design for manufacturability to decrease development time, minimize costs, and achieve speed to market.
We maintain strong R&D investment to develop new technologies that complement customer initiatives to incorporate electrical and optical capabilities into catheters. Throughout our partnership, we provide the mechanical design, process design, device testing, material testing, inspection, traceability, and documentation required to meet complex and sophisticated requirements. We support customers with the following catheter enabling platforms:
- Mechanical competencies in delivery platforms, materials joining and precision coating to develop miniaturized sensor, electrical, and optical components.
- Advanced electrical and optical design capabilities in fine wire joining, proximal ring connectors, sensor connector attachment, optical fiber connectors, optical fiber polishing, and wire bonding.
- Clinical and design assurance to perform benchmark testing, technology research, and clinical evaluation.