Active Sterile Medical Devices

Range of powered medical devices developed and manufactured under strict regulatory compliance. Products fall under active medical device classification requiring clinical validation and regulatory registration.

Dedicated manufacturing line for active medical devices with ISO 13485 quality management system compliance and regulatory compliance design development capabilities.

Range of certified medical devices for multiple healthcare applications. These products meet regulatory standards and support safe clinical practice.

General medical instruments meeting international quality and safety standards. Manufactured with advanced machining processes and certified ISO 13485:2016 and CE Class I for sterile and non-sterile applications.

ISO 13485-certified series production of medical devices with cleanroom facilities, internalized manufacturing processes, and sterilization-ready output.

Custom-designed medical devices manufactured under ISO 13485 certification with integrated research, development, and production quality assurance. Ensures regulatory compliance and validated biomedical performance.

Complete sterilization services for finished medical devices and components using validated methods. Ensures devices meet sterility assurance levels required for clinical use.

Range of Class II medical devices developed and manufactured according to regulatory standards. These moderately-risk devices undergo predefined quality controls and clinical evaluation procedures.

A range of Class I medical devices including basic medical instruments and equipment manufactured under regulated quality systems. Products comply with medical device classification and regulatory requirements.

Complete finished medical devices manufactured through end-to-end contract manufacturing services. Produced with ISO 13485 and FDA QSR compliance from design through assembly and sterilization.

Medical catheter and device products holding multiple domestic medical device registration certifications. Manufactured in compliance with national regulatory standards and quality requirements.

Custom-designed and manufactured equipment for production of medical devices in cleanroom environments, developed from extensive experience in sterile medical device manufacturing. Supports automated production processes compliant with EN ISO 13485 standards.