The company manages its supply chain using forecasts based on historical and anticipated demand. Lead times for components vary depending on order size, fabrication, testing, supplier requirements, and market demand. The company has experienced delays in obtaining components and subassemblies. It relies on single and limited source suppliers for key components, including optical fiber, coating and drive cables for catheters, and laser and data acquisition cards for the Lightbox, as well as assembly of the Lightbox 3. These components have few alternative sources, and identifying new suppliers may be time-consuming and costly. Supply interruptions or failure to secure additional vendors could negatively impact manufacturing capabilities and business results. The company continuously assesses supply chain risks and seeks second source suppliers as needed.
Manufacturing operations comply with regulatory requirements, including the FDA's Quality System Regulation (QSR) under 21 CFR part 820, the Medical Devices Directive 93/42/EEC, the EU-MDD to EU-MDR transition provisions, and environmental and safety regulations. The company is registered with the FDA as a medical device manufacturer and holds a manufacturing license from the California Department of Public Health. The FDA enforces QSR through inspections, including those of subcontractors. BSI conducted multiple audits in 2019, 2020, and 2021, including surveillance, microbiology, Medical Device Single Audit Program (MDSAP) re-certification, and an unannounced audit in September 2019.
Avinger Inc's Comment on Supply Chain
The company manages its supply chain using forecasts based on historical and anticipated demand. Lead times for components vary depending on order size, fabrication, testing, supplier requirements, and market demand. The company has experienced delays in obtaining components and subassemblies. It relies on single and limited source suppliers for key components, including optical fiber, coating and drive cables for catheters, and laser and data acquisition cards for the Lightbox, as well as assembly of the Lightbox 3. These components have few alternative sources, and identifying new suppliers may be time-consuming and costly. Supply interruptions or failure to secure additional vendors could negatively impact manufacturing capabilities and business results. The company continuously assesses supply chain risks and seeks second source suppliers as needed.
Manufacturing operations comply with regulatory requirements, including the FDA's Quality System Regulation (QSR) under 21 CFR part 820, the Medical Devices Directive 93/42/EEC, the EU-MDD to EU-MDR transition provisions, and environmental and safety regulations. The company is registered with the FDA as a medical device manufacturer and holds a manufacturing license from the California Department of Public Health. The FDA enforces QSR through inspections, including those of subcontractors. BSI conducted multiple audits in 2019, 2020, and 2021, including surveillance, microbiology, Medical Device Single Audit Program (MDSAP) re-certification, and an unannounced audit in September 2019.
Sources:
Avinger 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.
Updated on:
For your research, we’ve provided nine additional tables on Avinger Inc ’s suppliers.
You can find them in the navigation menu under Suppliers.
To download the tables, please subscribe.
Intraday data delayed per exchange requirements. All quotes are in local exchange time. Intraday data delayed 15 minutes for Nasdaq, and other exchanges. Fundamental and financial data for Stocks, Sector, Industry, and Economic Indicators provided by CSIMarket.com
Disclaimer: Information provided by CSIMarket.com is for informational purposes only and does not constitute investment advice, recommendation, or solicitation to buy or sell any security.
