Andy Leopold

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complex catheter systems insert molding & overmolding prototyping permanent implants testing services full manufacturing assembly packaging sterilization & lot release distribution & logistics material selection pilot production covered stents covered frames medical equipment manufacturing catheter manufacturing implant design biomedical textiles complex catheters bioabsorbable polymers device prototyping regulatory compliance quality assurance iso 13485 certified fda registered delivery systems verified medical devices concept to commercialization r&d engineering validation testing finished devices component manufacturing automated assembly medical device market syringe testing stent testing material technologies eptfe manufacturing nitinol components power injection testing radiopacity testing steerable catheters deflectable delivery systems custom manufacturing medical device certification quality control processes biologics release testing design verification safety & effectiveness cleanroom manufacturing engineering solutions risk management sustaining engineering transcatheter devices neurovascular devices peripheral vascular devices orthopedic implants gastroenterology devices urology devices interventional devices shipping logistics & supply chain medical devices hospital & health care