Medical Device & Hospital Supply Sourcing

No. Huntley Global is not an FDA consultant and does not provide regulatory clearance or certification services. What we do is source from factories that already hold relevant certifications (ISO 13485, FDA registration, CE marking) and provide you with all factory compliance documentation. You will need to work with a qualified regulatory consultant for FDA 510(k) or PMA submissions. We can recommend partners if needed.

Our vetted medical manufacturers typically carry ISO 13485 (medical device quality management), ISO 9001, FDA establishment registration, CE marking for EU markets, and GMP certification. We verify all certifications directly with issuing bodies before recommending any factory to a client.

Yes. We have sourced specialist pharmaceutical processing machinery at 81% below the domestic US market rate for a previous client. We specifically seek factories with pharmaceutical GMP certification and a documented export history to regulated markets. All specifications are verified against your requirements before production.

Pricing depends on throughput capacity, compliance requirements, and specification. We source from GMP-certified manufacturers with documented export history to regulated markets. Contact us for a tailored quote based on your specific requirements.

Every medical procurement order goes through our enhanced Quality Gate: factory certification verification, in-line production inspection, pre-shipment inspection against your specification, and a detailed written QC report with photographic evidence. Nothing ships without your explicit approval. For medical devices, we also obtain batch-specific test reports and certificates of conformity from the factory.