J
I am currently writing a procedure to define the design control requirements for sterile medical devices. Can anyone suggest a reference for the initial design choice: "does this device need to be sterile".
Usually this is an intuitive decision, but for a high level procedure I want to be able to offer a process for making the decision, and all of the standards I can find appear to assume that you have already made the choice before they become applicable.
Can anyone help me?
Yours, in hope!
JtB
Usually this is an intuitive decision, but for a high level procedure I want to be able to offer a process for making the decision, and all of the standards I can find appear to assume that you have already made the choice before they become applicable.
Can anyone help me?
Yours, in hope!
JtB

