ALD is awarded ISO 13485:2016 quality management system certification

As a high-tech enterprise focusing on the research and application of electronic atomization technology, ALD has been persisting in research and exploration in the field of inhalation medical atomization equipment for many years. Recently, ALD successfully passed the NSF-ISR assessment and officially obtained the ISO13485 quality management system certification.

ALD is awarded ISO 13485:2016 quality management system certification

According to data from the Prospective Industry Research Institute, the scale of my country’s medical device market exceeded 600 billion yuan in 2019, and the average annual compound growth rate in the next five years (2019-2023) is about 14.41%. It is predicted that my country’s medical device market will exceed the scale of 2023, reaching 10767 billion yuan. At the same time, with the COVID 19 epidemic sweeping the world, the demand for testing reagents, masks, ventilators and other medical products around the world has skyrocketed, which has greatly promoted Chinese medical device companies to go global.

The full name of ISO13485 is “Requirements for Medical Device Quality Management System for Regulations.” The certificate is an independent standard based on ISO9001, which sets specific requirements for the quality management system of medical device manufacturers, and represents the application company in product development, supplier management, production control, quality inspection and assurance, sales and after-sales service, and Management responsibilities, resource management and other aspects have passed a comprehensive and strict review and evaluation to ensure the safety and effectiveness of medical devices. In summary, ISO13485 certification is an important qualification endorsement for the circulation of medical devices in the international market.

ALD is awarded ISO 13485:2016 quality management system certification

For a long time, ALD has been strictly demanding itself with high industry standards. Through the establishment of a quality management system required by international standards, the configuration of high-standard automated production equipment in the industry, and strict product development, manufacturing, quality testing and after-sales service, etc. Standardize and control, and strive to provide customers with professional, efficient, stable and reliable one-stop service.

In the medical field, the inhalation atomizer is the key basic equipment for the treatment of modern respiratory diseases. Now ALD has made key breakthroughs in many aspects such as atomization conversion rate and aerosol particle size control. The passing of ISO 13485:2016 means that ALD’s medical device design, R&D, procurement, and production quality control have all reached the requirements of international standards, which symbolizes that ALD medical manufacturing has reached a new milestone.ALD is awarded ISO 13485:2016 quality management system certification

This “ISO 13485:2016” quality management system certification not only witnessed ALD’s years of hard work on the road of R&D innovation and reliable production, but also announced to the world ALD’s determination to deepen its cultivation in the atomizing medical industry. ALD not only has confidence in the industry and persistence in value, but also has a vision for change and a dedication to professionalism. In the future, atomization will be full of expectations and fantasy in the medical field, and ALD is always on the way!


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