The international standard, ISO 13485:2016, represents the requirements for a comprehensive quality management system for the design and manufacturing of medical devices. Our quality management system is ISO 13485:2016 certified which ensures that we have a controlled work environment, we fulfil the requirements of Inspection & traceability, regulatory & legal, corrective & preventive action verification, which guarantees product safety and effectiveness.
Our Everoshine and Trackmaster Everolimus-Eluting Coronary Stent System is a CE (Conformitè Europëenne) marked product. It conforms to the European health, safety, and environmental protection standards. Being a CE-marked product, our Everolimus stent is tested on the most stringent quality parameters and it has conformed with all the safety and performance requirements. Our product demonstrated exceptional performance in real-life clinical cases.
Our Stenoflex and Trackflex Sirolimus-Eluting Coronary Stent System is a CE (Conformitè Europëenne) marked product. It conforms to the European health, safety, and environmental protection standards. CE mark assures that our Sirolimus-Eluting Coronary Stent System performs as per its intended use and it gives maximum procedural successes with zero product malfunction. The results of product validation and verification studies demonstrate superior product quality which is the best of its kind.
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