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