Your Brand.
Our Infrastructure.
We provide the medical-grade substrate, precision manufacturing, and regulatory backbone. You provide the market access.
Fig 1. Precision Laser Marking Service
01 OEM Deployment Tiers
Neutral (Whitebox)
Unbranded boxes, standard labels. Ready for immediate resale or local relabeling.
- ✓ No branding restrictions
- ✓ Fast turnaround (7 days)
- ✓ Lowest MOQ (50 units)
Private Label
Your logo laser-etched on the disc edge. Your custom label design applied in-factory.
- ✓ Custom laser marking
- ✓ Packaging design support
- ✓ Mirror technical file
- ✓ MOQ: 500 units
Custom Formulation
Bespoke alloy adjustments (within ASTM standards) and exclusive form factors.
- ✓ Exclusive alloy formulations
- ✓ Custom dimensions
- ✓ Dedicated production runs
02 Regulatory Document Hosting
An OEM brand is only as safe as its paper trail. ValidTi provides a "Mirror Technical File" for every private label partner, ensuring you can pass a surprise audit by your local Competent Authority.
Regulatory Liability Shield
When you register a medical device under your brand, YOU become the legal manufacturer. ValidTi maintains a parallel technical file that mirrors your registration, providing backup documentation for FDA/MDR inspections.
Included Documents:
Fig 2. Mirror Technical File Structure
03 Custom Branding & Packaging Services
Laser Marking Specifications
High-precision fiber laser etching on disc rim or rod end. Permanent, autoclave-resistant marking.
| Parameter | Specification |
| Laser Type | Fiber (1064nm) |
| Resolution | 0.05mm Line Width |
| Character Size | Min. 2mm Height |
| Depth | 0.02-0.05mm |
Packaging Options
From neutral whitebox to full GTM-ready retail packaging with your brand design.
Plain white boxes with ValidTi logo only. Includes barcode and lot number labels.
Your brand label (supplied artwork) applied to standard ValidTi packaging.
Complete custom packaging design, print, and assembly. Requires 2000+ unit orders.
04 Client Success Stories
European Distributor Network
A regional distributor in Germany launched their house brand using ValidTi Tier 2 services. Achieved 40% margin improvement vs. reselling branded products.
Large Milling Center Chain
A network of 12 dental labs consolidated purchasing under their own brand. Reduced per-unit cost by 35% through volume commitments.
Startup Implant Brand
A new medical device startup used Tier 3 custom formulation to develop proprietary abutment blanks, now sold in 8 countries.
05 Global Logistics Parameters
| Parameter | Specification | Notes |
|---|---|---|
| Packaging Units | Individual / 10-Unit Bulk / Palletized | Custom packaging available |
| Lead Time (Stock) | 7 Days | For whitebox orders |
| Lead Time (Custom) | 21 Days | For branded/custom packaging |
| Shipping Incoterms | EXW Xi'an / FOB Shanghai / DDP | DDP available to select regions |
| Payment Terms | T/T, L/C, or Net 30 | Net terms for qualified accounts |
| Quality Hold Period | 48 Hours | Final inspection before shipping |
06 Technical File Audit Support
When your local authority (FDA, Notified Body, MDSAP auditor) requests supplier documentation, ValidTi provides immediate access to our complete technical file package.
Audit Survival Kit Includes:
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Supplier Quality AgreementPre-signed template with QA commitments
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Certificate PackageISO, FDA, CE, MDSAP certified copies
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Batch DocumentationMTR, CoA, and test reports per lot
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Change Control RecordsProcess validation and revision history
MDR Transition Support (2025)
EU Medical Device Regulation (MDR) 2017/745 requires updated technical documentation. ValidTi's files are MDR-ready and include:
- ✓ Unique Device Identification (UDI) compliance
- ✓ Clinical evaluation reports (CER)
- ✓ Post-market surveillance procedures
- ✓ Economic operator declarations
Initialize Partnership
Private label partnerships require business verification. Submit your application with business license and distribution portfolio.
⚠️ STRICTLY B2B // BUSINESS LICENSE REQUIRED // MOQ APPLIES
Confidentiality & Non-Compete
ValidTi guarantees absolute confidentiality for all private label partnerships. We do not sell directly to end-users in your territory and will not approach your clients. Your brand equity is protected by NDA and territorial exclusivity agreements (where applicable).