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First of all, thank you all for the great topics on the board, fantastic information gathering board.
We are producing custom made medical devices and for process validation there are a lot of external trainings available, but I cannot find any training which focusses on process validation of custom made devices.
Does anyone has experience with the AAMI training and if they address custom made products?
Or does anyone know any good training for process validation with focus on custom made devices, ideally in Europe, but if the trainings are worth it we can send some people to other parts of the world or invite the trainer to Europe.
Thanks!
We are producing custom made medical devices and for process validation there are a lot of external trainings available, but I cannot find any training which focusses on process validation of custom made devices.
Does anyone has experience with the AAMI training and if they address custom made products?
Or does anyone know any good training for process validation with focus on custom made devices, ideally in Europe, but if the trainings are worth it we can send some people to other parts of the world or invite the trainer to Europe.
Thanks!