Software validation for the medical devices industry


I recently completed building a platform combining four UR Cobots (2UR3 & 2UR5) to create an assembly system for a medical device. As part of the system validation I am obligated to SW validation based on the medical devices regulations (both FDA and CE). My question is - did anyone encounter this issue? how did you solve it? are there SW validation documents available from UR?

Thank you,

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