The company utilizes both internally manufactured and externally sourced components for its medical device systems. For the LimFlow system, it relies exclusively on externally sourced components, third-party contract manufacturing, and finished goods assemblies. These components include off-the-shelf materials, sub-assemblies, and custom parts from approved suppliers, some of which are single-source. Supplier risk is managed through quality and capacity assessments, supply and quality agreements, lead time and inventory management, and efforts to identify alternative suppliers for dual or multi-sourcing. The company maintains sufficient supply levels to prevent interruptions and estimates up to six months to qualify a second source for certain components. Suppliers are evaluated, qualified, and approved via a supplier quality program that ensures compliance with FDA and ISO standards. Externally sourced components undergo inspection and verification under strict processes, and finished products are sterilized by qualified third-party suppliers.
Inari Medical Inc's Comment on Supply Chain
The company utilizes both internally manufactured and externally sourced components for its medical device systems. For the LimFlow system, it relies exclusively on externally sourced components, third-party contract manufacturing, and finished goods assemblies. These components include off-the-shelf materials, sub-assemblies, and custom parts from approved suppliers, some of which are single-source. Supplier risk is managed through quality and capacity assessments, supply and quality agreements, lead time and inventory management, and efforts to identify alternative suppliers for dual or multi-sourcing. The company maintains sufficient supply levels to prevent interruptions and estimates up to six months to qualify a second source for certain components. Suppliers are evaluated, qualified, and approved via a supplier quality program that ensures compliance with FDA and ISO standards. Externally sourced components undergo inspection and verification under strict processes, and finished products are sterilized by qualified third-party suppliers.
Sources:
Inari Medical 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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