Software validation for the medical devices industry

[naor.benish]

Hi,

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,
Naor

[devidmiler565]

@naor.benish

Hi,

I recently completed building a platform combining four UR Cobots (2UR3 & 2UR5) to create an gold loan 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,
Naor

Thanks buddy for asking looking the answer for the same question. I am following your thread to get related answer.