Medical device outsourcing business

We turn your idea into the medical product.

Consistent support for design, manufacturing to product Launch.

Please contact us if you do not have a factory for manufacturing medical devices,
we can turn your idea into product by developing and manufacturing medical devices complying with
international medical regulations and laws.

Medical device outsourcing business

With the combination of one stop end to end manufacturing outsourcing service and world-class quality assurance system, we closely work together with our customers to manufacture medical devices for not only Japan but also European and the US markets.

Medical device production flow

Development plan
QMS ConstructionMedical devices strategy support
Specification development
PlanRequirement specificationsRisk management
Basic design
Product standardPrototypingVerification
Mass production prototyping
Manufacturing evaluationVerificationValidation
Application for Government Medical Regulations support
Production
Product standardParts procurementQuality control and storage
Product Launch
Market introductionSales promotionPost-marketing surveillance study
Medical device OEM /ODM

Design and contracted manufacture

We have more than a half century of manufacturing outsourcing experiences, high-precision manufacturing technology and procurement ability that makes full use of domestic and overseas supply chain network.

Design and contracted manufacture
On your behalf

Support medical laws and regulations clearance

We can provide outsourcing services for manufacturing including support for medical laws and regulations clearance based on experiences and expertise as a registered manufacturing and marketing company by Japanese law.

Support medical laws and regulations clearance
Compliance with laws and regulations in Japan and overseas

World-class quality assurance

We have manufacturing capability with a quality assurance system that complies with Japanese Medical Regulations, ISO 13485, MDR in Europe and 21 CFR Part 820 (QSR U.S. FDA).

World standard quality assurance