Medical Device Parts
FDA compliant surgical instrument components manufactured to the highest medical standards
Project Overview
This medical device project demonstrates our capability to manufacture FDA-compliant surgical instrument components with exceptional precision and cleanliness. The parts are designed for critical medical procedures and require the highest levels of quality assurance.
Manufactured in our ISO 13485 certified clean room facility, these components undergo rigorous testing and validation to ensure they meet all regulatory requirements. Our team follows strict protocols for material traceability, sterilization compatibility, and biocompatibility.
Material
316L Stainless Steel
Tolerance
±0.001"
Quantity
1,000 Units
Lead Time
4 Weeks
Compliance & Quality Standards
Meeting the most stringent medical device manufacturing requirements
FDA Compliant
Full compliance with FDA 21 CFR Part 820 regulations
ISO 13485
Certified medical device quality management system
Clean Room
Class 10,000 clean room manufacturing environment
Full Traceability
Complete material and process documentation
Manufacturing Capabilities
Advanced processes for medical device component production
Precision Machining
- Swiss-type turning
- Multi-axis milling
- Micro machining
- Mirror surface finish
Material Testing
- Biocompatibility testing
- Material certification
- Sterilization validation
- Corrosion resistance
Quality Inspection
- 100% inspection
- CMM measurement
- Surface roughness testing
- Visual inspection
Clean Room Manufacturing
Quality Control Testing
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