Your Design. Our ISO 13485 Factory.
Contract manufacturing for medical-grade titanium components. From prototype to production, with full regulatory compliance.
01 Manufacturing Equipment & Capacity
| Category | Equipment | Capacity Range | Typical Applications |
|---|---|---|---|
| Swiss Turning | Citizen Cincom A20/A32 (12 units) |
Ø3-32mm | Abutment screws, healing caps, transfer copings, surgical pins |
| 5-Axis Milling | Hermle C30U (4 units) |
Ø98-200mm | Full-arch bridges, implant bars, complex anatomical parts |
| Turning Centers | Haas ST-10/ST-20 (6 units) |
Ø50-250mm | Large diameter components, surgical instrument handles |
| Quality Control | Zeiss CMM + Optical Comparator | ±0.002mm | First article inspection, dimensional verification, SPC monitoring |
02 Manufacturing Quality Variability
Risk Addressed
Dimensional Inconsistency & Non-Compliance
Every batch undergoes First Article Inspection (FAI) with full dimensional CMM report. Statistical Process Control (SPC) monitors critical dimensions throughout production run. ValidTi provides batch-specific MTR and inspection certificates.
Fig 1. CMM First Article Inspection - Dimensional Verification ±0.002mm
03 Quality Assurance Protocol
Stage 1: FAI
First Article Inspection with full CMM dimensional report verifying all critical features match technical drawing.
- ✓ 100% dimensional verification
- ✓ Material cert validation
- ✓ Process capability (Cpk) calculation
Stage 2: SPC
Statistical Process Control monitors critical dimensions during production run. Real-time alerts prevent drift.
- ✓ Control charts (X-bar/R)
- ✓ In-process inspection (every 25 pcs)
- ✓ Automated tolerance alerts
Stage 3: Final QA
100% visual inspection, random CMM sampling (10%), and batch documentation package.
- ✓ Surface finish verification
- ✓ Lot traceability labeling
- ✓ MTR + inspection report packaging
04 MOQ & Commercial Terms
Minimum Order Quantities
Design validation, clinical trials, regulatory submissions. Includes full FAI report and 3 sample parts for destructive testing.
Pilot production, limited market launch. Setup amortized over smaller quantities. Lead time: 3-4 weeks.
Full commercial production. Volume pricing, dedicated production runs, consignment inventory available.
Lead Time & Pricing Structure
| Component | Lead Time |
| NDA Review | 24 hours |
| DFM Analysis & Quote | 3-5 business days |
| Tooling/Fixturing | 7-10 days (if required) |
| Prototype (10-50 pcs) | 2-3 weeks |
| Production (500+ pcs) | 4-6 weeks |
Expedited prototype runs (7-10 days) available with priority fee. Contact for feasibility assessment.
05 NDA & Intellectual Property Protection
Confidentiality Guarantee
ValidTi treats all client designs, technical drawings, and specifications as strictly confidential. We do not manufacture competing products or share your IP with third parties.
- Mutual NDA: Standard template available, or use your own legal document
- Secure File Transfer: Encrypted CAD file upload portal with access logging
- No Reverse Engineering: Parts manufactured strictly to your specifications only
Design Ownership & Rights
You retain 100% ownership of all design IP, tooling, and production processes developed for your project.
What You Own:
- ✓ Original CAD files and drawings
- ✓ Process parameters and CNC programs
- ✓ Custom fixtures and tooling (if purchased)
- ✓ Quality control procedures
- ✓ All technical documentation (FAI, SPC, MTR)
06 Regulatory Compliance & Certifications
ISO 13485:2016
Medical Device Quality Management System. Notified Body: NQA. Scope: Precision machining of titanium medical device components.
View Certificate →FDA Registered
Establishment No. 3033849259 (Active). Contract manufacturer of medical device components. Annual FDA inspections passed.
Verify Registration →MDSAP Certified
Medical Device Single Audit Program. Covers USA, Canada, Australia, Brazil, Japan regulatory requirements simultaneously.
Certificate available on requestSubmit Technical Drawing for Quote
Upload your CAD files (.STEP, .IGES, .STL) or PDF technical drawings. Our engineering team will respond within 24 hours with DFM analysis and formal quotation.
NDA available upon request. IP protection guaranteed. Secure file transfer.