The company sources raw materials specific to each part or device and continuously assesses tooling and equipment. Order quantities and lead times from external suppliers are determined based on forecasts derived from historical and anticipated demand. Lead times vary depending on order size, fabrication and testing duration, supplier requirements, and market demand. The company has not experienced significant product availability or delay issues related to components. Suppliers undergo regular audits to ensure compliance with quality system requirements, including QMSR and ISO standards. The company is an FDA-registered medical device manufacturer certified to ISO 13485:2016 and participates in the Medical Device Single Audit Program (MDSAP), recognized in Australia, Brazil, Canada, Japan, and the United States. It complies with applicable federal, state, and local regulations concerning laboratory practices, animal use, hazardous substances, working conditions, manufacturing, environmental protection, and fire hazard control.
Atricure Inc's Comment on Supply Chain
The company sources raw materials specific to each part or device and continuously assesses tooling and equipment. Order quantities and lead times from external suppliers are determined based on forecasts derived from historical and anticipated demand. Lead times vary depending on order size, fabrication and testing duration, supplier requirements, and market demand. The company has not experienced significant product availability or delay issues related to components. Suppliers undergo regular audits to ensure compliance with quality system requirements, including QMSR and ISO standards. The company is an FDA-registered medical device manufacturer certified to ISO 13485:2016 and participates in the Medical Device Single Audit Program (MDSAP), recognized in Australia, Brazil, Canada, Japan, and the United States. It complies with applicable federal, state, and local regulations concerning laboratory practices, animal use, hazardous substances, working conditions, manufacturing, environmental protection, and fire hazard control.
Sources:
Atricure 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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