Pioneering Respiratory Interface Solutions for Global Healthcare
Table of Contents
Pioneering Respiratory Interface Solutions for Global Healthcare #
Company Overview #
Established in 1986, GaleMed has dedicated itself to building a sustainable enterprise rooted in the principles of mutual benefit, innovation, satisfaction, and the pursuit of excellence. Our mission is to foster growth and learning, enabling employees, customers, and suppliers to achieve shared success and prosperity.
Specializing in the research, development, production, and marketing of respiratory therapy products, GaleMed serves the needs of emergency and respiratory care professionals worldwide. Our comprehensive product portfolio includes solutions for:
- Airway management
- Breathing support
- Oxygen therapy
- Aerosol therapy
- Humidification
- Sleep therapy
- Lung function training
We are committed to becoming the world’s leading brand in respiratory therapy interface technology, offering a full spectrum of products that bridge the gap between users and machines, as well as between technology and humanity. Our focus is on developing, manufacturing, and marketing interface products that support first aid, care, treatment, and training, ensuring safe and reliable solutions for respiratory professionals.
GaleMed’s dedication to progress is reflected in our market-leading products, many of which offer unique value propositions. In 1995, we became a pioneer in the respiratory accessory and component sector by obtaining ISO 9001, EN46001, and CE certifications, establishing a strong foundation and respected position in the industry.
Our Philosophy #
Business Philosophy #
- Win-win: We believe in creating value for all stakeholders—customers, shareholders, suppliers, and employees—ensuring mutual satisfaction and success.
- Innovation: Continuous innovation in concepts, products, and systems is vital for maintaining vitality and sustainable growth.
- Satisfaction: Achieving satisfaction for customers, suppliers, employees, and shareholders is our ultimate goal and the highest standard of management.
- Enrichment: The pursuit of enrichment drives our progress, enabling us to enhance business performance and achieve greater profitability.
Locations & Markets #
Rooted in Asia, Serving the World #
- Global Reach: Distributing to over 100 countries through a robust network of distributors and subsidiaries.
- Team Strength: Over 650 employees across four sites in Asia.
- Comprehensive Portfolio: More than 5,000 SKUs, making us a one-stop shop for respiratory therapy solutions.
Regulatory Compliance & Certifications #
GaleMed is committed to the highest standards of quality and regulatory compliance. Our quality management systems and product certifications include:
Quality System #
- EN ISO 13485:2016
- ISO 9001:2015
- Taiwan TFDA QMS
- Korea GMP
- Japan Registration Certificate of Foreign Medical Device Manufacturer
Product Certification #
- CE Certificate
- FDA Listing and 510(K)
- Mainland China Registration for Medical Devices
- Taiwan Registration for Medical Devices
Additional Certifications #
- ISO13485, MDSAP, FDA QSM, TÜV Rheinland, DNV, Taiwan GMP, and Japan GMP
- Medical device quality certifications for CE, US FDA, Canada, Korea, Japan, Taiwan, and China
Awards and Recognition #
GaleMed’s commitment to innovation and quality has been recognized with numerous awards, including:
- Taiwan SME Innovation Award for Sil.Flex™ Stoma Pad
- Taiwan Industrial Innovation Achievement Award for nVCM Resuscitator
- Taiwan Healthcare Industry Innovation and Excellence Silver Award
- National Small and Medium Enterprise Award
- National Rising Star Award
- Golden Merchant Award
- National Biomedical Quality Award
- Taiwan Excellent Product Award for MR-100TM Manual Resuscitator
- Taiwan Excellent Product Award for CPR-Super Pocket Mask
- D-U-N-S® Registered™ Certificate
For more information about our products, services, and company milestones, please explore the following resources: