Manufacturing System for General Medical Devices
For manufacturing and marketing the DWX series, Roland DG has obtained the licenses for Medical Devices Marketing Authorization Holder and Medical Device Manufacturer pursuant to Pharmaceutical Affairs Law (PAL), which regulates the manufacturing, importation, and sale of drugs and medical devices in Japan (Medical Device Marketing Notification Number of DWX-50: 22B3X10006000020).
The DWX series is produced in a dedicated manufacturing space for medical devices, which is separated from the assembly area of the other products, such as printers and general milling machines, which are not for medical use. At the entrance of the medical device manufacturing area, a hand wash sink and a space to change uniforms have been provided for sanitary control. The DWX series is built using specific Digital YATAI units which are certified to manufacture medical devices. Also, along with the DWX-dedicated YATAI, Roland DG developed “special YATAI” units equipped with electrical safety testing devices to undertake tests required when manufacturing medical devices.
Through this sanitized, safe, and efficient manufacturing system, Roland DG has produced the precision DWX series in accordance with PAL, regarded as one of the most stringent medical-related laws in the world