Vascotube produces tubing exclusively for the medical device industry. The vast majority of our tubes are going to be parts of FDA class III medical devices, such as stents and heart valve frames.
We do value this fact: we carry numerous in process inspections at all different process steps. We have invested in sophisticated inspection and analysis equipment to be able to look beyond the first sight. We make cross-sections of every lot that we produce and hold retention samples of every lot that we ship.
Quality control and inspection equipment include:
SEM Scanning Electron Microscope, EDX analyze unit, 3D Laser Confocal Microscope 1000x, Metallurgical Microscope 2000x, Endoscope, Stereo Light Microscopes 20x and 40x, Zeiss Microscope 120x, DSC Differential Scanning Calorimetry, Af-Tester, Eddy Current Testing, Zwick Tensile Test equipment 2,5kN up to 50kN, Laser Micrometer, Surface Roughness measurement unit, Mahr Wall thickness measurement.
Quality inspection process is managed in a specialized IT system. Each article gets its own specified inspection plan. The measuring equipment is directly linked to the IT system. The data is stored in a change recorded IT environment and is related to the unique production lot number. We save all data on our two parallel secured servers and do hold copies in a separate location.
Due to our specialization on the medical device industry we are also certified ISO 13485, the medical device standard, for more than 12 years now. We have passed a high number of audits from notified bodies, as well as from customers, including renowned US medical device companies.