As an ISO13485 certified and registered medical device manufacturing and marketing company by Japan law, we are rich in experience and knowledge of the entire medical device manufacturing process through own brand product manufacturing and launch. Those accumulated skills and expertise are fully utilized in order to meet and exceed customer outsourcing expectations.

Medical device production flow

Product planning
Development plan
Specification development
Basic design
Mass production prototyping
Application for Government Medical Regulations
Production
International support
Product Launch

Own brand products:Arteriosclerosis measuring device

Own brand products:Arteriosclerosis measuring device

Equipment class Class II
Medical device category Diagnosis
Commissioned phase Product planningDevelopment planSpecification developmentBasic designManufacturingOverseas (U.S.A)
Contents Design and manufacture of in-house products, overseas expansion (U.S.A, Asia)

Own brand products:Pain measuring device

Own brand products:Pain measuring device

Medical Device Class Class II
Medical device category Diagnosis
Worked phase Product planningDevelopment planSpecification development Basic designManufacturing
Contents Design and manufacture of in-house products

Deliverable products:Blood flow measurement devices

Deliverable products:Blood flow measurement devices

Medical Device Class Class II
Medical device category Diagnosis
Worked phase Specification developmentBasic designManufacturing
Contents Design, prototyping, mass production

Deliverable products:Surgical medical devices

Deliverable products:Surgical medical devices

Medical Device Class Class II
Medical device category Diagnosis
Worked phase Development planSpecification developmentBasic designManufacturingOverseas (U.S.A.)
Contents Design and manufacture of FDA-compatible medical devices

Deliverable products:Oral and surgical instruments

Deliverable products:Oral and surgical instruments

Medical device category Others
Worked phase Manufacturing (processing)
Contents Metal cutting
Surgery:SUS630 For dentistry:Pure Titanium
Surgery:5-axis processing machine・MC For dentistry:NC Lathe
Surgery:To ensure smooth operability by devising finishing and surface treatment.
For dentistry:Microfabrication + upper tolerance 0.005, establish mass production system