The brief
When products protect workers or support patients, there is no room for error. Certification, traceability, compliance, and consistency are essential.
FDA / CE Certified Supply
A complete scope, one partner.
What we cover
Masks, gloves & gowns
The Process
Certified. Traceable. Compliant. Medical sourcing managed with precision at every step.
Starting Point
Requirement Specification & Compliance Brief
Define your product requirements, target certifications (FDA, CE, ISO), regulatory destination market, intended end-use, and volume needs. We help you map exactly what is required before any supplier is approached.
1–2 Weeks
Supplier Identification & Regulatory Verification
We identify suitable manufacturers from our network of FDA-registered and CE-certified facilities, verifying current certification status and compliance documentation before any engagement.
1–2 Weeks
Factory Audit & Due Diligence
For new suppliers or high-risk product categories, we conduct on-site factory audits covering manufacturing standards, quality management systems, and traceability protocols. Audit reports are made available to clients.
1 Week
Price Negotiation & Quotation
We negotiate pricing with approved factories, presenting transparent quotations that include unit price, certification fees, testing costs, and logistics. No hidden charges.
1 Week
Order Confirmation & Technical Documentation
All technical specifications, labelling requirements, regulatory declarations, and packaging standards are formally submitted. Export documentation requirements are established from the start to avoid downstream customs issues.
2–4 Weeks
Pre-Production Sample & Compliance Testing
Samples are reviewed for conformity and submitted to accredited third-party testing laboratories where required. All test reports are shared with the client before bulk production is authorised.
30–60 Days
Bulk Production & In-Process Monitoring
Production is monitored closely for compliance, quality management protocols, and batch consistency. Traceability documentation is maintained throughout.
1 Week Before Shipment
Final Quality Inspection & Certification Check
Final AQL inspection verifies product quality, labelling accuracy, packaging integrity, and regulatory documentation. Certification validity is re-confirmed before goods are released for export.
Ocean: 2–5 Weeks / Air: 3–5 Days
Export, Compliance Documentation & Shipment
Full export documentation including certificate of conformity, test reports, and customs declarations is prepared. Temperature and handling requirements are confirmed for regulated products.
Ongoing
Post-Delivery Support & Traceability Records
Batch and traceability records are retained and available on request. Any compliance queries or product issues are managed directly with the factory on the client's behalf.
Take the next step in your sourcing journey.
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One source. Infinite possibility.
Tell us what you need to source.
Send a brief or a product reference. We'll come back with the right factories, honest pricing, and a plan to deliver.