Would you like to bring your medical device to life? We accept OEM and ODM for medical devices.
There is no factory to make medical devices." "This is the first time developing a medical device product." "I want to expand the product overseas.
Please leave the design and manufacturing of medical devices and regulatory support to us. We will turn your ideas into reality. 【Features】 ■ A comprehensive system from design, procurement, prototyping, mass production, to regulatory compliance ■ Quality assurance system for medical device manufacturing and sales, medical device manufacturing, and ISO 13485 ■ Cleanroom with an area of over 900 square meters (equipped with air showers and clean benches) ■ Experience with audits and inspections from various countries: FDA (USA), CSA (Canada), MFDS (Korea), NMPA (China) *For more details, please refer to the PDF document or feel free to contact us.
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basic information
【Design】We perform mechanical, electrical, and software design based on ISO 13485. - Support for formal testing such as electrical safety and EMC, risk management, and cybersecurity. 【Manufacturing】We undertake manufacturing as a medical device manufacturer. - We establish processes from purchasing, receiving, manufacturing, inspection, to shipping in accordance with the agreed QMS. 【Regulatory Support】We accompany you from the establishment of medical device entry and overseas expansion to market launch and post-marketing. - Support for QMS construction, obtaining business permits, and regulatory application support. - Procurement of overseas products and manufacturing of overseas shipments.
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Applications/Examples of results
In-house products - Blood pressure pulse wave measurement device - Sensory and pain quantification analysis device OEM/ODM achievements in ME equipment - Blood flow measurement device - Wireless biosensor - Immunoassay device, etc. Regulatory support achievements - Support for acquisition and operation of manufacturing and sales licenses - Support for QMS construction, etc. *For more details, please refer to the PDF document or feel free to contact us.
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Company information
◇Over half a century of experience and knowledge in manufacturing ◇A system of design, manufacturing, and quality assurance well-versed in overseas regulations ◇And the spirit of manufacturing recognized by a company that owns its own products These are our strengths in ensuring the effectiveness, safety, and quality maintenance of our products. We are committed to daily challenges in developing products, technologies, and services that are competitive on a global scale.
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