From prototype development to full-scale production, we deliver tubing that’s engineered for your application and ready for clinical success.
At Impact Catheters, we are committed to providing our customers with superior personalized service that meets your medical product needs. Our product application engineers will recommend the best materials based on your application.
We specialize in custom and standard tubing for medical devices, supporting projects from prototype to production.
Our extrusion processes ensure tight tolerances, smooth surfaces, and reliable performance.
We passed our ISO 13485 audit on the first attempt thanks to their quality system team. They structured our DHF, CAPA, and risk management processes in a way our internal team finally understood.
As a startup, we had zero quality infrastructure. They built our entire QMS from scratch, SOPs, training records, NCR process, and had us audit-ready in under six months.
Their dual ISO 13485 and ISO 9001 expertise was exactly what we needed to satisfy both our FDA and EU MDR compliance teams simultaneously. Incredibly efficient and knowledgeable consultants.
Impact Catheters was able to help us with our custom catheter needs. We simply filled out the form and were helped by their team. I will continue to use them for our catheter needs.
