How can you validate a Vante catheter manufacturing system?
Vante’s systems are the only systems which provide quantifiable, validatable process parameter inputs and outputs useful toward ISO/GMP documentation and validation. Vante is an ISO 13485:2003 certified company, as well as, FDA Registered. Our systems were designed specifically for catheter manufacturing and to support process validation. VANTE’s Catheter Manufacturing Systems are the only RF systems on the market to offer Patented Closed-Loop Temperature Control. We provide precise control of all process parameters including : Heat Time, Cool Time, and Pressure. We control temperature to +/- 1 Degree C on PIRF II and +/- 1% of target temperature on PIRF III and Saffire.
