With our 20+ years of experience, Machine Solutions has provided innovative testing equipment that is designed to measure trackability, torquability, and pushability of your interventional device for competitive testing or device validation.
MSI’s catheter testing equipment and the IDTE equipment can help validate your device to the following international recommendations:
ISO (2003). ISO 25539-1 Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses.
ISO (2000). ISO/TS 15539 Cardiovascular implants – Endovascular prostheses.
FDA guidelines – guidance for industry and FDS staff non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems