Regulations

ISO 13485:2016
ISO 13485:2016 is the international standard for quality management systems for medical devices.
By obtaining this certification, we maintain high quality standards in the design, manufacture and sale of our products.

Medical Device Manufacturing Registration Certificate
We have obtained the necessary registrations to manufacture medical devices.
This proves that our manufacturing processes are operated under proper controls.

Type 2 medical device manufacturing and sales license
As a manufacturer and distributor of medical devices,
We supply medical devices with appropriate quality control and post-market safety management systems in place.

License for the sale and rental of highly-regulated medical equipment
We are licensed to sell and rent specially controlled medical equipment.
This has established a system for the proper supply of highly safe medical devices.

Medical equipment repair business license
We have obtained a medical equipment repair license.
We have a system in place to carry out appropriate maintenance and repairs.
This allows us to provide a service that our customers can use with peace of mind.