The company manufactures its products using raw materials, some of which are sourced from single suppliers; however, it considers additional sources to be readily available or capable of in-house production if necessary. Its manufacturing facilities in Eden Prairie, Minnesota, and Ballinasloe, Ireland, are certified to ISO 13485 and registered with the U.S. FDA as Contract Manufacturers. Additionally, one manufacturing facility and a warehouse in Eden Prairie, Minnesota, hold ISO 9001 certification. The company adheres to quality management procedures aligned with applicable regulations and guidance for the development and manufacture of materials and device, biotechnology, or combination products supporting clinical trials and commercialization.
Surmodics Inc's Comment on Supply Chain
The company manufactures its products using raw materials, some of which are sourced from single suppliers; however, it considers additional sources to be readily available or capable of in-house production if necessary. Its manufacturing facilities in Eden Prairie, Minnesota, and Ballinasloe, Ireland, are certified to ISO 13485 and registered with the U.S. FDA as Contract Manufacturers. Additionally, one manufacturing facility and a warehouse in Eden Prairie, Minnesota, hold ISO 9001 certification. The company adheres to quality management procedures aligned with applicable regulations and guidance for the development and manufacture of materials and device, biotechnology, or combination products supporting clinical trials and commercialization.
Sources:
Surmodics 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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