Suppliers provide components and sub-assemblies for the production of iRhythm ACM Systems, including circuit boards from contract electronic manufacturers. The manufacturing team manages these suppliers, while the quality team monitors compliance with specifications and regulatory requirements such as FDA QMSR, EU MDR, UK MDR, and Japanese QMS. Certain components and materials, including application-specific integrated circuits for transmitters, seals for applicators, and polymers for polymeric membranes used in sensors, are sourced from single suppliers due to quality, cost, or regulatory considerations. Manufacturing facilities hold EN ISO 13485:2016 certification, and device establishments are registered with the FDA and the UK’s MHRA.
Irhythm Holdings Inc's Comment on Supply Chain
Suppliers provide components and sub-assemblies for the production of iRhythm ACM Systems, including circuit boards from contract electronic manufacturers. The manufacturing team manages these suppliers, while the quality team monitors compliance with specifications and regulatory requirements such as FDA QMSR, EU MDR, UK MDR, and Japanese QMS. Certain components and materials, including application-specific integrated circuits for transmitters, seals for applicators, and polymers for polymeric membranes used in sensors, are sourced from single suppliers due to quality, cost, or regulatory considerations. Manufacturing facilities hold EN ISO 13485:2016 certification, and device establishments are registered with the FDA and the UK’s MHRA.
Sources:
Irhythm Holdings 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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