The company sources critical raw materials and components, including those from Chinese and Taiwanese manufacturers, often from single suppliers. While it has not experienced significant supply interruptions, it recognizes risks related to global supply chain disruptions, trade restrictions, pandemics, and geopolitical events. The company maintains at least a three-month inventory of materials from sole suppliers and pursues additional sourcing options when feasible. For example, the non-magnetic ultrasonic motor used in its MRI-compatible IV infusion pump was previously solely sourced from a major multinational Japanese manufacturing company until December 2024, when the company entered into a technology transfer and license agreement to manufacture the motors internally. The company implements quality management practices, conducts supplier assessments, and holds ISO 13485 and Medical Device Single Audit Program certifications, which were renewed in October 2024 and remain valid through January 2028.
Iradimed's Comment on Supply Chain
The company sources critical raw materials and components, including those from Chinese and Taiwanese manufacturers, often from single suppliers. While it has not experienced significant supply interruptions, it recognizes risks related to global supply chain disruptions, trade restrictions, pandemics, and geopolitical events. The company maintains at least a three-month inventory of materials from sole suppliers and pursues additional sourcing options when feasible. For example, the non-magnetic ultrasonic motor used in its MRI-compatible IV infusion pump was previously solely sourced from a major multinational Japanese manufacturing company until December 2024, when the company entered into a technology transfer and license agreement to manufacture the motors internally. The company implements quality management practices, conducts supplier assessments, and holds ISO 13485 and Medical Device Single Audit Program certifications, which were renewed in October 2024 and remain valid through January 2028.
Sources:
Iradimed Corporation'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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