Medical Devices&Dentistry

Core parts cover

Surgical instrument handles(curved/complex shapes ),orthopedic aiming device,medullary canal files

Dental implant abutments (customized),dental hand-piece housings

Precision structural component for diagnostic equipment (PCR thermal covers,Ultrasound probe housings)

Rehabilitation device joint components micro-surgical forceps jaws

Drawbacks

Extremely high requirements for material bio-compatibility -full material certificated and batch traceability required

Stringent surface finish requirements -no burrs ,sharps edges ,or machining residue was permitted

Full traceability required batch-individual parts may required unique serialization

Some parts are micro -sized (minimum features<1mm)--different on clamp and measure

Clean-room packaging required to avoid contamination

Our Approach

Operated UnderISO13485 quality management system framework (Certificated where applicable)

Dedicated medical production line-physically isolated from industrial parts processing areas to prevent cross-contamination

Post-processing includes ultrasonic cleaning+Vacuum packaging

Each parts individually packaged with has its own dimension inspection record (not batch sampling )

Can assist with documentation required for FDA registration upon request

Case

We are a contract manufacturer that supplies precision -machined components for intramedullary nail targeting /aiming devices ,serving an orthopedic equipment company in shanghai,the material was 17-4PH precipitation -hardening stainless steel,required hardness HRC38-42 and edge break radius≤0.2mm,by optimizing the heat treatment curve and developing custom chamfering tools ,we improve yield rate from 72% during trial runs to 98.6% in full production.