Status: FDA Listed

Protocol: Regulatory Shielding

How a California-based Implant Brand launched a private-label disc line in 90 days with zero regulatory friction using ValidTi's "Audit-Ready" OEM infrastructure.

Execution Timeline (Days)

Day 0

Contract Signed

Day 14

Packaging Proof & Labeling Check

Day 45

FDA Device Listing Updated

Day 90

Market Launch

01 The Liability Gap

The client faced a critical risk: sourcing from generic Alibaba suppliers meant they became the "Manufacturer of Record" in the eyes of the FDA, assuming 100% liability for material defects they couldn't verify.

The ValidTi Solution

We acted as the Contract Manufacturer under our own FDA Establishment Registration (FEI: 3033849259). The client utilized our "Private Label" protocol, where ValidTi holds the Technical File (DMR) and manages the Device History Record (DHR), shielding the brand from manufacturing audits.

Deliverables Package

FDA 510(k) Equivalence PROVIDED
UDI (Unique Device Id) Gen GENERATED
Custom Packaging (Box + Label) PRINTED
IFU (Instructions for Use) INSERTED

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