Achieve product commercialization of medical devices through design and development that meets the requirements of the ISO 13485 process.
Sekiaoi Tech Co., Ltd. has obtained "ISO13485" and "Medical Device Manufacturing" certifications to ensure that medical device manufacturers can safely and securely outsource development and manufacturing to us. We provide comprehensive services that combine not only development and manufacturing but also implementation, top delivery, maintenance, and after-sales support. We can accommodate both new projects and design changes. (We can also propose alternative designs for discontinued parts.) 【*Exhibiting at 2019 MEDIX Kanto】 ISO13485 and Medical Device Manufacturing - Medical Device ODM and EMS Services In addition to supporting domestic medical devices, our factory in China also obtained ISO13485 certification in April 2019, and we are expanding our medical device development and manufacturing! *For more details, please refer to the PDF document or feel free to contact us.
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**Main Service Contents** ■ Medical Device ODM/EMS ○ In-house integrated system from design, prototyping, mass production to after-sales - Acquired ISO13485 and medical device manufacturing license - Development and design that meet the requirements of ISO13485 - Short lead-time prototyping suitable for evaluation and prototyping "Implementation TOP Service" - Mass production system based in Japan and China - Maintenance and after-sales service for medical devices with long product life cycles - VE activities made possible by the in-house integrated system
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All technology is for quality. ~Quality-oriented Engineering~ Since its establishment in 1964, Sekiaoi Techno has been engaged in the design, prototyping, and mass production of electrical, software, housing, mechanism, and AW products across a wide range of fields under the concept of "pursuing customer satisfaction through total solutions" for over 40 years. ◆ Complete support from upstream to downstream ◆ We handle various designs for assembly and procurement of parts in-house, leading to implementation and inspection before delivery to customers. ◆ Various certifications and support systems for customer peace of mind ◆ Compliance with domestic Pharmaceutical Affairs Law GMP/QMS regulations Manufacturing license 23BZ290013 International standards ISO 13485/9001/14001 ◆ Implementation of green procurement ◆ Konica Minolta certified environmental collaboration factory Efforts to comply with RoHS ■ For more details, please contact us.