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The software in your manufacturing processes,
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Quality assurance system software,
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Infrastructure system software in production areas,
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Software used for process management,
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Management software for monitoring products/raw materials and operational activities,
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Data processing Excel spreadsheets,
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Embedded software that are part of your medical device,
They shoul be validated in accordance with EN ISO 13485, IEC 62304, ISO/TR 80002, FDA, and GMP standards and regulations.
