The Company sources certain components and processes through third-party manufacturing partners to enhance operational efficiency and control production costs. It conducts activities such as subassembly, system configuration, performance testing, packaging, and labeling at its own facilities and occasionally at customer sites. Both the Company and its manufacturing partners adhere to regulatory requirements, including the FDA Quality System Regulation and other applicable federal, state, and international standards. The Company collaborates with its strategic partner, Neusoft Medical Systems, for research and development, utilizing their expertise in the design, engineering, and manufacturing of advanced medical imaging systems. For regulatory testing and evaluation of its next-generation PET-CT system, the Affinity™, the Company engages Intertek, an independent testing and certification organization, to perform safety and performance testing necessary for FDA submission.
Positron's Comment on Supply Chain
The Company sources certain components and processes through third-party manufacturing partners to enhance operational efficiency and control production costs. It conducts activities such as subassembly, system configuration, performance testing, packaging, and labeling at its own facilities and occasionally at customer sites. Both the Company and its manufacturing partners adhere to regulatory requirements, including the FDA Quality System Regulation and other applicable federal, state, and international standards. The Company collaborates with its strategic partner, Neusoft Medical Systems, for research and development, utilizing their expertise in the design, engineering, and manufacturing of advanced medical imaging systems. For regulatory testing and evaluation of its next-generation PET-CT system, the Affinity™, the Company engages Intertek, an independent testing and certification organization, to perform safety and performance testing necessary for FDA submission.
Sources:
Positron 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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