Daikiosan and Makano water purifiers meet international ISO standards for medical equipment

Daikiosan, Makano and other brands of Dai Viet Group are the first and only brands to meet this standard - Photo: MD

ISO 13485:2016 standard granted to Daikiosan and Makano fresh alkaline ionized water purifiers is an internationally recognized standard for quality management systems in the medical device industry.

According to Decree 36 issued on May 15, 2016 by the Prime Minister, ISO 13485 standard is one of the mandatory requirements for businesses trading and manufacturing in the field of medical equipment.

Accordingly, ISO 13485 is an international standard specifically for quality management systems in the medical device sector.

This standard is designed to ensure that organizations involved in the manufacture, installation and maintenance of medical devices can meet stringent safety and quality requirements.

Products are manufactured at the company's factory in Hai Son Industrial Park (Long An province) - Photo: MD

This indicator focuses on medical devices. This regulation not only requires product quality but also includes requirements for product safety compliance for users.

Next, the product must ensure process control. The standard emphasizes the establishment and strict control of the process to minimize risks and ensure product consistency. Companies need to establish a system to control the production process and check quality at each stage.

The factory of the unit owns the best and only clean room in the water industry in Vietnam to produce filter cores, components in contact with water, and post-filtration - Photo: MD

Product manufacturers must manage risks. ISO 13485 requires organizations to have a risk management plan and conduct a risk assessment for their medical products. This helps to minimize potential risks that could cause harm to users.

Next is the traceability requirement. The standard requires the organization to maintain traceability of products from design, production to distribution. This is important in ensuring that products can be recalled or controlled in the event of a safety issue.

Fresh alkaline ion products are diverse, from standing cabinets to under-counter, tabletop, and wall-mounted – Photo: MD

Finally, there is the requirement for continuous improvement. Although it does not require continuous improvement like ISO 9001, ISO 13485 still encourages organizations to continually improve their quality management system to better meet customer and regulatory requirements and expectations.

Achieving ISO 13485:2016 once again affirms the ability to meet international quality standards of Daikiosan and Makano fresh alkaline ionized water purifiers. At the same time, it demonstrates Daikiosan and Makano's commitment to developing cutting-edge technology, providing comprehensive health care solutions from fresh alkaline ionized water.

6 months after launching fresh alkaline ionizer, Daikiosan, Makano sold 8 times more than the market each year

Dai Viet Group's sales department, Daikiosan and Makano fresh alkaline water ionizer brands, said that after 6 months of launching, the unit has sold 50,000 machines and strives to reach 80,000 sets by the end of this year.

Although not a medicine, fresh alkaline ionized water is recommended by medical experts that if people use fresh alkaline ionized water that meets standards and is used properly, it will bring many benefits.

The reason is that the high pH in fresh alkaline water will help balance the acid in the body, supporting improvement for people with stomach pain, gastric reflux or constipation, digestive disorders. Those who suffer from such conditions should drink fresh alkaline water every day.

Recently, the company's product won the award "Most Favorite Alkaline Ionized Water Purifier" at the Tech Awards 2024 program (the most prestigious technology award in Vietnam) - Photo: MD

Source: https://tuoitre.vn/may-loc-nuoc-daikiosan-makano-dat-tieu-chuan-iso-quoc-te-ve-trang-thiet-bi-y-te-20241121084520466.htm