Supporting new entrants! Design development and manufacturing of medical devices and analytical equipment.
Regarding medical devices, we will create documentation related to design development and manufacturing as required by QSR, IVDR, and the Pharmaceutical and Medical Device Act.
OEM System is engaged in a comprehensive process from development to manufacturing (mass production) of devices and equipment. For over 30 years, we have specialized in the design, development, and manufacturing of medical devices and analytical instruments, with many products being sold overseas, which has provided us with extensive know-how in obtaining UL certification and CE marking. Additionally, all products are manufactured and inspected in-house, ensuring high quality. 【Numerous achievements with well-known domestic and international manufacturers】 "We are struggling because we lack know-how in development." "We cannot allocate resources for mass production in-house." "We want to enter the medical device market as well." Please feel free to consult with us first.
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basic information
We specialize in the development and manufacturing of primarily medium-sized lots, focusing on the medical, analytical, and life sciences fields. Management System ISO 13485 Certification Medical Device Manufacturing Registration Number: 26BZ000180 Our QMS complies with FDA QSR / IVDR. <Several of our products are registered with the FDA.>
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Applications/Examples of results
Liquid handling equipment Microplate absorbance spectrophotometer UV-Visible microplate reader HPLC application device
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Company information
The company name "OEMS System" not only includes the initials of our specialized technical fields—Optics, Electronics, and Mechanics—but also embodies our commitment to creating integrated systems that combine software technology to contribute to society. Our engineers, well-versed in the life sciences and clinical testing fields, develop equipment tailored to our customers' needs. High-quality products are meticulously crafted by skilled production engineers and manufacturing staff at our factory, which is dedicated to Japanese manufacturing. We deliver these products to customers around the world, including Japan, North America, Central and South America, Europe, the Middle East, Asia, and Africa, earning high trust from many people along the way. Moving forward, we will continue to develop and manufacture equipment that contributes to society through our comprehensive technical capabilities in planning, development, manufacturing, and quality control, providing products that satisfy our customers.