Regulatory & market assessment
Requirements and deliverables are confirmed for the agreed product, market and manufacturing scope.
— OEM / PRIVATE LABEL / CONTRACT MANUFACTURING
From product concept to
market-ready IVD manufacturing.
Build a project brief for private label diagnostic tests, contract manufacturing for rapid tests, FIA products, PCR test kits or IVD technology transfer—without unsupported capacity, certification or performance claims.
— CONTROLLED PROJECT PATH
Six stages. One traceable brief.
Product & technical definition
Requirements and deliverables are confirmed for the agreed product, market and manufacturing scope.
Packaging & brand adaptation
Requirements and deliverables are confirmed for the agreed product, market and manufacturing scope.
Feasibility, validation & documentation
Requirements and deliverables are confirmed for the agreed product, market and manufacturing scope.
Manufacturing & quality release
Requirements and deliverables are confirmed for the agreed product, market and manufacturing scope.
Logistics & market supply
Requirements and deliverables are confirmed for the agreed product, market and manufacturing scope.
— MANUFACTURING LOCATION
Where should your product be manufactured?
Production location can change according to the destination market, regulatory pathway and delivery point. Vision evaluates verified sites and partner routes; no country recommendation is automatic.
Target sales marketRegistration and regulatory pathwayCountry-of-origin expectationsLocal-content or tender advantagesCustoms and import structureDelivery time and logisticsCold-chain requirementsAnnual volumeTechnology-transfer requirementManufacturing-site documentation
— OEM PROJECT BRIEF
Define the product, market and manufacturing route.
Customer targets for performance, shelf life, storage or platform compatibility remain proposed requirements until feasibility and validation are completed.
What we evaluate before manufacturing.
Technical feasibilityProduct classificationRegulatory pathwayLegal manufacturer structureSite requirementsQuality documentationPackaging and localisationValidation requirementsOrder volumeProduction planningLogistics and market access
Each project is evaluated independently. Registration, certification, capacity and delivery are confirmed only after controlled review.
— OEM FAQ
Clear answers before project start.
Can Vision manufacture under our brand?
Private-label projects are evaluated against technical feasibility, quality documentation, target-market requirements and agreed commercial scope.
How is the manufacturing location selected?
The team evaluates market access, country of origin, logistics, customs, volume and local-content requirements before recommending a verified production route.
Which certificates are required?
Requirements depend on product classification, intended use, legal-manufacturer structure and the competent authority in the target market.
Can we submit our own formulation or reference product?
Yes. Existing formulations, specifications and comparator information can be submitted securely for project review.
Can packaging and IFUs be localized?
Label, packaging and IFU language requirements can be included in the project brief and assessed for the target market.
What happens after submission?
Vision reviews technical, regulatory, packaging, volume and logistics inputs before confirming feasibility and the next controlled project stage.