The company sources sub-assemblies and components for the manufacturing of Quell and DPNCheck devices, as well as consumables such as biosensors and electrodes, from suppliers. Due to low production volumes, many key components have limited alternative suppliers. The company maintains close relationships with local suppliers that meet FDA, ISO, and other quality standards. Supplier performance is managed through a corrective action program. Since 2005, a New England regional supplier has manufactured devices and sub-assemblies, currently producing sub-assemblies for Quell and DPNCheck. A full-service OEM in the central United States manufactures DPNCheck biosensors and Quell electrodes. The company performs inspection, final assembly, packaging, and labeling at its manufacturing facility. It is registered with the FDA and ISO and undergoes regular audits and inspections to ensure compliance.
Neurometrix Inc's Comment on Supply Chain
The company sources sub-assemblies and components for the manufacturing of Quell and DPNCheck devices, as well as consumables such as biosensors and electrodes, from suppliers. Due to low production volumes, many key components have limited alternative suppliers. The company maintains close relationships with local suppliers that meet FDA, ISO, and other quality standards. Supplier performance is managed through a corrective action program. Since 2005, a New England regional supplier has manufactured devices and sub-assemblies, currently producing sub-assemblies for Quell and DPNCheck. A full-service OEM in the central United States manufactures DPNCheck biosensors and Quell electrodes. The company performs inspection, final assembly, packaging, and labeling at its manufacturing facility. It is registered with the FDA and ISO and undergoes regular audits and inspections to ensure compliance.
Sources:
Neurometrix Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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