Industry
Medical Devices
Medical components leave no margin for error. Our ISO 13485-certified molding and machining cells, documented traceability and validated cleaning make us a dependable manufacturing partner for device OEMs shipping into regulated markets.
Your challenges
What keeps Medical procurement teams up at night
Regulatory documentation burden (FDA / MDR) demands full material and process traceability
Biocompatible materials and cleanroom-compatible handling are non-negotiable
Design revisions must not compromise validation already completed
Our response
Capabilities that match
Plastic Injection Molding
Medical-grade polymers, dedicated 13485 cells, USP Class VI / FDA material options
View capability →CNC Machining
Surgical instruments & device components in 17-4PH, titanium and PEEK
View capability →Finishing & Assembly
Class 100K assembly zone, validated cleaning and packaging
View capability →Compliance
Certifications & documentation
- ISO 13485:2016 certified QMS
- USP Class VI / FDA compliant material options
- Full DHR-ready batch records
- Validation support: IQ/OQ/PQ documentation
Track record
Typical parts we make
- Surgical instrument handles
- Diagnostic device housings
- Drug-delivery components
- Dental tool bodies
- Fluid-management fittings
Request for Quotation
Have a drawing? Get a quote in 24 hours.
Upload your STEP / IGES / 2D drawings and receive a costed quotation with DFM feedback — typically within one business day.
Reply within 2 business days · NDA available on request