The software in your manufacturing processes,
Quality assurance system software,
Infrastructure system software in production areas,
Software used for process management,
Management software for monitoring products/raw materials and operational activities,
Data processing Excel spreadsheets,
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.
