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Established in 1986, GaleMed aims to create a sustainable learning and growth enterprise with the spirit of mutual win, innovation, satisfaction, and pursuit of excellence, which enables employees, customers, and suppliers to achieve win-win and common prosperity. GaleMed is specializing in R&D, production, and marketing of respiratory therapy products in emergency and respiratory therapy. The current products cover "respiratory tract management", "breathing", "oxygen treatment", “aerosol treatment", "humidifying treatment" and "sleep", "lung function training“. GaleMed aims to be the world's leading brand of respiratory therapy interfacing technology by providing a full range of interfacing technologies in the field of respiratory therapy to meet the needs of our customers. GaleMed ‘s products are positioned as the interface technology for respiratory therapy professionals, providing the interface products between users and machines, as well as the interface services between technology and humanity. Therefore, GaleMed focuses on the development, manufacturing, production, and marketing of respiratory interface products in the field of respiratory therapy, providing all kinds of interface products for first aid, care, treatment, and training between respiratory ventilation equipment and upper respiratory tract. GaleMed strives to make progress and aims to provide users with safe and reliable products. GaleMed has a number of products not only the first in the market, but also the with a unique value proposition. In 1995, GaleMed was the leading company to obtain ISO 9001, EN46001 and CE certification, in the respiratory accessory & component sector across the world, which was highly respected, and has achieved a solid foundation and position. Our Philosophy Business philosophy Wise: Win-win - means win-win. Customers, shareholders, suppliers and employees can all win and be satisfied with each other. Innovation is the meaning of Innovation, including Innovation in concept, product and system. Only with Innovation can we have vitality and sustainable business. Satisfaction - The management of an enterprise should achieve the Satisfaction of customers, suppliers, employees, and shareholders. This is the goal of running an enterprise, and it is also the highest level. Enrichment - The pursuit of Enrichment, is the driving force for the growth of the enterprise, and only continuous progress, in order to improve business performance, obtain higher profits. Locations & Markets Stands In Asia Serve the World 100+ countries Distributing to over 100 countries worldwide. Through a network of distributors and subsidiaries. 650+ employees 650+employees across 4 sites in Asia. 5,000+ SKUs There are more than 5,000 SKUs in our category. As a one stop shop fulfillment center to make the shopping experience more efficient than ever before. Regulatory & Certifications GaleMed has been actively involved in developing, manufacturing and marketing respiratory care products. Our success begins with our ability to apply our innovative ideals in combination with our technology to an endless array of customer needs. 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 device Taiwan Registration for Medical device Certifications Medical Device Registrations : ISO13485, MDSAP, FDA QSM,TÜV Rheinland, DNV, Taiwan GMP and Japan GMP Medical devices quality : CE, US FDA, Canada, Korea, Japan, Taiwan and China Awards and Recognition 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®RegisteredTM Certificate
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GaleMed had been built up by its original founder for the past 30+ years to be a very reputable player in the respiratory and anesthesiology sector. GaleMed is an innovative R&D-driven manufacturer and supplier operating at the global level to bring high-quality solutions in this specialty space. We work with globally leading brands to serve hospitals, home care centres, patient centres, and even aerospace. With its own brand GALEMED, GaleMed sells its products all over the world, and its products have gained a foothold in the field of respiratory therapy, and it has become the OEM partner of many world-class medical device enterprises. Galemed is not complacent about this. Understanding that brand promotion is equally important to products and sales, and actively understanding and analyzing the current situation of industry competitors/ourselves and future advantages and disadvantages opportunities. Promoting our own brand, develop a brand strategy, and carry out a series of brand development plans. GaleMed has a long history in ODM background, and we were generating a new vitality by creating niche products, developing new corporate identification system, repositioning many product brands, and promoting various plans to enhance the innovation value and brand loyalty as the goal, for the next decades. Iconic Brand GaleMed is positioned as a multi-brand strategy to differentiate different customer groups and extend the brand into different areas, including Babi.Plus for infant and infant respiratory care, Dezire for sleep therapy, Humi-Aide for humidification therapy, and Oxi.Plus for oxygen therapy. The multi-brand strategy shows the strong ambition of GaleMed, and it also understands that for different brand positioning and product demands, GaleMed must carefully understand the differences in markets and demands around the world, analyze the advantages and disadvantages of internal and external situations and opportunities, and carry out the brand introduction and development plans according to different market demands and opportunities. Neonatal Respiratory Care Humidification Therapy Sleep Therapy Aerosol Therapy GiO™ Manometer Oxygen Therapy Product Value - Safety First GaleMed not only attaches importance to the invisible bonus points of brand exposure and quality impression in promotion but also archives five principles in product research and development: safety, comfort, convenience, uniqueness, and affinity. We hopes that the image demand of professional, high-quality products and high-quality service can achieve the internal and external consistency of GaleMed Spirits. 01 Safety The safety and effectiveness of medical devices is our major goal. 02 Convenient An excellent medical device that is convenient and easy to use. 03 Comfortable Optimal comfort, ergonomic design for the caregivers and patients. 04 Environment Environmental control for products and facilities. 05 Unique We offer unique solutions and design to health care use.
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2023 GaleMed Xiamen China site was awarded European MDR certificate. Certificate No. HZ 2058519-1 – CertipediaGaleMed I-Lan site was awarded European MDR certificate.Certificate No. HZ 2100418-1 – Certipedia 2019 Nexus Point Capital 2018 Automated import 2017 SAP online 2013 Breathe Home Experience Centre 2009 Winner of Taiwan Healthcare Industry Innovation and Excellence Silver Award 2008 2nd Xiamen Facility established 2007 APlus Medical launched in USA Establishment of APlus Medical Supplies in China 2006 1st Xiamen Facility established 2005 GaleMed became an employee owned corporation 2000 GaleMed Taiwan GaleMed Corporation 1996 National Excellence Award for MR-100 Manual Resuscitator and Pocket Resuscitator Produces more than one million manual resuscitators in a year 1995 Company renamed GaleMed Corporation 1988 FDA Certified Facility Starts to specialize in respiratory care products 1986 Founded by Gary Lee Formosa-CJ Health Business Corporation established
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CRUISE WITH SUSTAINABILITY GaleMed has been deeply involved in the development and manufacturing of respiratory and anesthesia consumables for 35 years. Every action we take may have an impact far beyond our business scope. We strive to integrate sustainability into all aspects of our business and prioritize the highest quality standards in order to build a more transparent, ethical and resilient company. We strike a balance between long-term growth and profitability and our contribution to employees and partners, the environment and the global community. We work hard to obtain safe and reliable medical product technology for medical staff and patients every second. Our initiatives to improve inclusiveness, diversity and fairness affect our employees and our communities. Our environmental management affects our lives. We continue to promote the meaning of becoming a goal-oriented company, co-prosperous with customers, suppliers, employees and other stakeholders, and strive to connect with society for the benefit of the world. GaleMed five missions, visions and sustainable strategies When WISE X ESG GaleMed's Five Sustainability Strategies Environmental Satisfaction In response to green production, it emphasizes carbon reduction from materials and packaging, and exerts an influence on suppliers. Green Operation Pursuing corporate operational efficiency is our goal, and we hope to achieve the rights and interests of stakeholders, and we are committed to environmentally sustainable development. Corporate Governance Global Governance Strengthen the governance structure and comply with international laws and regulations. Innovation Combining the brainstorming of professional respiratory therapy and engineering experts to provide customers with the most competitive products and services. All Win Achieve the highest satisfaction of shareholders, customers, business partners and employees satisfaction. Overview of ESG implementation in GaleMed 5 Main Policies Develop a supplier code of conduct Fully comply with pollution emission standards Pay attention to industrial safety and environmental protection Implement ESMS and EHS specifications Colleagues participate in person Environment Regulation Regulation Comply with local regulations and licensing requirements Waste Management Waste Management Comply with waste management guidelines, pollution emission limits and obtain appropriate permits Environmental Policy Environmental Policy A number of policies, such as off-site environmental management guidelines, production environmental guidelines, to ensure compliance with the relevant regulatory requirements Society We Bring Green To You Social insurance Xiamen Payment of social insurance Housing provident fund payment is in line with the industry average standard Taiwan Pension contributions and labor/health insurance in compliance with local regulations Employee rights and benefits Leave benefits in accordance with local regulations Overtime benefits are in full compliance with local regulations Take the initiative to provide other benefits to employees Replace orders with communication, and bring consensus to coordination The quarterly GaleMed Academy offers a wide range of general education programs Promote the labor health service system and safeguard the safety and health of workers Employee health and safety Inspect the occupational hazard condition in the factory regularly Provide regular health check for plant staff Online care and parties Work from home hardware and software resource allowance Flexible family care policy The social responsibility During the COVID-19 epidemic, the Xiamen factory donated consumables to help Wuhan Yilan factory donated to rare disease organizations and participated in local scholarship programs During the epidemic outbreak, employees were given subsidies for working from home, and masks were distributed monthly Innovation Academic research Technical support, technical authorization Production and medical exchanges, production and school cooperation Clinical trials and demand feedback Continuous product development, innovation and improvement Production safety Set up relevant policies and procedures, such as production safety management and warehouse management guidelines to ensure the production safety of all areas Safety project: correct non - conformance safety requirements (fire safety, elevator safety, etc.) Health and safety monitoring and management in the production process, for Yilan and Xiamen factories. Continuous industrial hygiene monitoring, occupational medical monitoring, and inform employees occupational hazard procedures Governance Buy Green And Save Green ESG Compliance GaleMed established an ESG promotion group to consolidate the three major aspects of economy, society and environment, and follow the international ESG guidelines, requiring the supply chain and business operations to follow exactly. Risk assessment Through existing factory or written audits, we will actually check whether it meets ESG requirements, and compare the validity of a standard certificate and implementation process. Validating and confirming the management mode of uncertified suppliers or partners. Continuous promotion and improvement Regular communication meetings are held to regularly review the status of the company's internal achievements, as well as actively encourage partners to meet the standards. GaleMed Value GaleMed continues to refine the manufacturing technology and design services of respiratory and anesthesia consumables. To comply with Global ESG Standards, continues to bring more advanced, more powerful, more energy-efficient, and safer products, greatly enhance the quality of life, and move towards a sustainable Good society. Contact Us
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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. GaleMed Corporation QMS CertificateGaleMed Corporation EN ISO 13485：2016 ISO 9001:2015 TFDA QMS0053 TFDA QMS5376 EN ISO 13485：2016 ISO 9001:2015 TFDA QMS0053 TFDA QMS5376 MDR CE CertificateGaleMed Corporation MDR HZ 2100418-1 MDR HZ 2100418-1 MDR HZ 2100418-1 MDR HZ 2100418-1 Japan Registration CertificateGaleMed Corporation Registration certificate of foreign medical device manufacturer BG10600026 Registration certificate of foreign medical device manufacturer BG10600026 Registration certificate of foreign medical device manufacturer BG10600026 Registration certificate of foreign medical device manufacturer BG10600026 GaleMed (Xiamen) Co., Ltd. QMS CertificateGaleMed (Xiamen) Co., Ltd EN ISO 13485：2016 ISO 9001:2015 MDSAP EN ISO 13485：2016 ISO 9001:2015 MDSAP MDR CE CertificateGaleMed (Xiamen) Co., Ltd MDR HZ 2058519-1 MDR HZ 2058519-1 MDR HZ 2058519-1 MDR HZ 2058519-1 CFDAGaleMed (Xiamen) Co., Ltd NMPA NMPA NMPA NMPA Japan Registration CertificateGaleMed (Xiamen) Co., Ltd Registration certificate of foreign medical device manufacturer BG10500245 Registration certificate of foreign medical device manufacturer BG10501343 Registration certificate of foreign medical device manufacturer BG10500245 Registration certificate of foreign medical device manufacturer BG10501343 Registration certificate of foreign medical device manufacturer BG10500245 Registration certificate of foreign medical device manufacturer BG10501343