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HoneyNaps has obtained the international medical device quality management certification 'ISO 13485'

Reported by Financial News / Jul 26, 2022

"The first sleep tech company to achieve 'iso 13485:2016' certification in korea domestic."

"Establishing an international medical device standard quality management system to lay the foundation for global market expansion"

On the 21st, HoneyNaps, a sleep specialized company, announced that it has become the first domestic sleep tech company to obtain the international medical device quality certification, ISO 13485. The certification signifies that the management system for the development, production, and service of sleep analysis medical devices is compliant with international standards, establishing a foundation for entry into the U.S. market.

ISO 13485 certification is a system that verifies whether a company possesses a management system and quality management system that meets international requirements, from the development to the production of medical devices. It is a standard established by the International Organization for Standardization (ISO).

In particular, the medical field tends to have more rigorous certification procedures and requirements compared to other industries.

Among them, ISO 13485 certification is a crucial certification that can only be obtained by meeting the stringent quality management standards required by countries such as North America and Europe. Companies that have obtained this certification are recognized as having the qualification to export medical devices to major countries around the world.

The HoneyNaps quality management representative expressed their delight in being the first domestic sleep specialized company to obtain ISO 13485 certification, particularly in a time when the awareness of the importance of sleep is increasing both domestically and internationally due to the COVID-19 pandemic. They stated, "We are pleased to announce that HoneyNaps has obtained ISO 13485 certification. With our innovative technologies that meet global standards, we are committed to leading the advancement of the sleep industry."


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