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Khemraj Singh replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls 10 years 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.