TOKYO, March 29, 2021 — Casio Computer Co., Ltd. announced today that Yamagata Casio Co., Ltd., its manufacturing subsidiary in Japan, has acquired ISO 13485 certification for medical device quality systems, effective March 8, 2021. The certification provides assurance that the company safely manufactures and supplies medical devices. This will enable Casio to further improve the reliability and accelerate the development of its medical devices business in international markets.
ISO 13485 is an international standard for quality management systems (QMS) for the medical devices industry. The standard applies to organizations in the medical devices industry which are involved in designing, manufacturing or installing medical devices, or which provide associated services, or those that design, develop or provide related services. ISO 13485 has been incorporated as a basis for the implementation of quality management methods into government regulations on medical devices in countries around the world, including Japan. An increasing number of countries are requiring ISO 13485 certification for medical devices, and it has become virtually essential for doing business, particularly in the U.S. and Europe.
The ISO 13485 certification acquired by Yamagata Casio covers the design and manufacturing of medical devices and covers products that have already been released including the DZ-D100 DERMOCAMERA™ for skin observation and DZ-S50 dermoscope for close-up skin observation. It will also cover other medical cameras for healthcare that Casio plans to develop and release.
Going forward, Casio will build sales networks in major markets including the U.S. and Europe, while expanding into other medical fields beyond dermatology to contribute to healthcare.
“DERMOCAMERA” is a trademark or registered trademark of CASIO Computer Co., Ltd., Japan.