Medical Division

At a medical equipment exhibition a few years ago, we received inquiry whether Fujiiseiko could manufacture medical parts using our super-precision manufacturing technology. Today, we now achieved techniques to produce several types of parts for special medical devices. We specialize in areas that require extremely fine precision. Installation of clean rooms and introduction of new processing machines are proceeding, and we endeavor on parts production, hoping that the medical division will be one of Fujiiseiko’s top business in the near future.

MEDICAL DEVICE MANUFACTURING ENVIRONMENT

Precision processing, measurement, and sterilization in the clean environment of Class 1,000 Cleanroom
In a class 1,000 clean room, precision processing of ultra-small parts is being performed using Wire cut, Machining center, and Small molding machines. After processing, parts go under sterilization and cleaning, then automatic measurement and inspection are carried out with an Image measuring machine.

2015Medical device manufacturing launched
Aug 2017Operation of Fujiiseiko QMS:FMS based on ISO13485:2016 started.
Aug 2018FDA Supplier Audit for products to USA. Approved.
Aug 2019ISO13485:2016 certification acquired.
Dec 2019EN ISO13485:2016 certification acquired.
Jus 2020New medical facility scheduled to be completed.
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