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Khemraj Singh replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls 8 years, 5 months ago
Legacy devices can be existing devices, modified hardware, and modified software. Legacy medical devices should conform to IEC 62366, a standard that specifies usability requirements for the development of medical devices. Having a summary of known use errors is a good start. A full use-related risk analysis should be performed. Primary operating functions should be documented. Application specification should also be documented.