Commitment to Global Medical Device Quality and Compliance

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Commitment to Excellence in Quality and Regulatory Compliance
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GaleMed is dedicated to achieving the highest standards in quality management and ensuring compliance with global medical device regulations. Our products, widely used in respiratory and anesthesia care, serve millions of patients worldwide each year. We prioritize safety and effectiveness, continually refining our production processes in line with our Quality Policy: “Zero defect in products and services” and “The most satisfactory quality service.”

As a medical device manufacturer, GaleMed adheres to the requirements set by health authorities in each country, including but not limited to ISO 13485, MDSAP, JGMP, and QMS-TW. Our products are certified or approved for marketing in various regions, such as under EUMDR, US FDA 510K, NMPA (cFDA), Health Canada, and TFDA. Regular audits and reviews ensure our factories and products consistently meet regulatory standards.

We maintain a robust quality management system, continuously monitoring and updating our procedures to align with evolving business needs and regulatory requirements. Our ongoing commitment to improvement ensures that our products and services meet both clinical demands and customer expectations.