Syprosoft has deep experience with surgical products including devices used to perform the surgery and visualization devices used during surgery. Surgical devices include lasers and catheters used to treat atrial fibrillation and angina. We also have experience with Holmium:YAG lasers used for spinal procedures such as discectomy and foraminoplasty, and laser lithotripsy to remove stones in the bladder, kidneys, ureters or urethra. Visualization devices include various endoscopic and imaging systems used in the operating room. We have extensive knowledge of the stringent regulatory requirements for higher risk surgical products. Descriptions of some sample projects follow.
Laser SurgeryDeveloped test protocols for double pulse laser delivery fibers used for incision, excision, vaporization, ablation and coagulation.
Arthroscopic Video Performed V&V for an arthroscope with a tablet console. Developed all documents and an automated test strap for stress testing.
Balloon Inflator Developed a prototype automated balloon inflator to bring consistency to valve deployment procedures.
Endoscopic SystemPerformed software risk management for a high-definition endoscope. Used FMEA and FTA based risk analysis and developed unit tests.
Heart Valve CrimperDeveloped a crimper used to compress large size nitinol and stainless steel stent valves prior to deployment by catheter.
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Trans-Myocardial RevascularizationQualified an upgraded laser by performing efficacy tests that demonstrated no impact on the creation of myocardial channels during a TMR procedure.