Cosmic Me has been developing and manufacturing various medical devices since its establishment. In particular, we are good at developing electronic control units, which are the heart of electronic devices, and in particular, we have received high praise from many customers in circuit design and firmware design. We also develop and manufacture medical equipment other than electronic medical equipment.
Our motto is to create products that meet customer requirements and are highly effective and safe. We aim to be a product that truly satisfies our customers by responding quickly and flexibly to changes in specifications.
Compared to general electronic devices, medical electronic devices have many regulations that must be cleared. Specifically, you must prove that you meet the specific requirements of your product classification, such as electrical safety and electromagnetic compatibility (EMC).
We are familiar with standards such as JIS T0601-1,2, which are required as medical electronic device certification and approval standards. When designing and developing medical electronic devices, we will proceed with the process with due consideration to meet the standards.
As a medical device manufacturer, we can manufacture products to completion and ship them to distributors. Medical devices can only be manufactured by a publicly licensed business operator. We are fully equipped with a manufacturing and quality control system that complies with the Pharmaceutical Affairs Law and international standards (ISO), and are working on the manufacture of medical devices.
We also manufacture surgical medical devices classified as Class III (highly controlled medical devices) under the medical device business license.
In order to sell a medical device on the market, you must obtain marketing approval or certification for the medical device. We have a Type 1 medical device manufacturing and sales license, and we can apply for manufacturing and sales of medical devices up to Class IV (highly controlled medical devices) in the classification.
Even if the customer has obtained the permission only for the sales business, or if there are circumstances such as being unable to apply for certification by himself, we can apply for certification and supply it to the customer on an OEM basis after obtaining the certification. is. We handle a wide range of tasks, from document preparation to negotiations with the authorities, so that certification can be obtained quickly.