Regulations and Quality

Achieving the highest standard of Quality Management system, similarly compliance with worldwide the medical device regulations.

GaleMed’s products are used in respiratory and anesthesia field to treat millions of people around the world every year. Without compromising the safety and effectiveness of GaleMed’s products, GaleMed continue to optimize the production process to follow the Quality Policy of GaleMed “Zero defect in products and services” and ” The most satisfactory quality service”.

GaleMed, as a medical device manufacturer, must meet the requirements of the local health authorities of each country for quality management systems, such as: ISO 13485 quality management system standards, MDSAP, JGMP, QMS-TW, etc. Similarly GaleMed’s products have been certified or approved to be marketed on the certain region and countries, such as: EUMDR , US FDA 510K clearance, NMPA(cFDA), Heath Canada, TFDA, etc. In the period of be a license and certification holder, GaleMed has been undergone audits and review regularly to ensure that the factories and it’s products comply with medical device regulations suitability.

GaleMed has continuously monitored and managed it’s quality management system to ensure that the procedures and processes fulfil the business needs and comply with the updating and reviewing requirements of each competent authority. In the meantime, GaleMed keeps improvement and ensures that the quality of our products and services meets clinical needs and customer expectations.