P
Philip1983
Hello to everybody at the Cove
I am looking for some advice about a validation of a Class I Medical device.
It's a metal part which is CNC turned and after a heat treatment and then surface treatment (electro polished).
For the CNC part we are planning to do a OQ and PQ with MFK, SPC with retrospective IQ because the machines are installed since a long time.
What would you suggest for the heat treatment and surface treatment?
I am really lost and everybody thinks I am the big specialist and knows what to do. :-(
I only have big experience with sterilizer validations for class III devices.
Thanks for any help you can give me.
I am looking for some advice about a validation of a Class I Medical device.
It's a metal part which is CNC turned and after a heat treatment and then surface treatment (electro polished).
For the CNC part we are planning to do a OQ and PQ with MFK, SPC with retrospective IQ because the machines are installed since a long time.
What would you suggest for the heat treatment and surface treatment?
I am really lost and everybody thinks I am the big specialist and knows what to do. :-(
I only have big experience with sterilizer validations for class III devices.
Thanks for any help you can give me.