High Level Validation Plan template for a Medical Device

I need an example of a validation plan template for a medical device - does anyone have a high level example?

Hi Alice,

it would be good to know for what purpose you need, and also some info would be good about the QMS environment.
O yes, the high level template ... I have attached one I had used for software.
But again, it is alone does not solve too much, there have to have SOPs to control the final product and it is rarely a plan. Its execution involves even more documents to come.

If your device is a software, FDA Guidance for SW validation. (but alone It used to make almost zero sense to me )


Regards
Szabolcs

Are you purely looking at process validation?

What sort of detail would you expect to see?

Hello Achorste

I am looking at product validation for a medical device. We have determined all the various tests that need to be performed mostly through FMEA and risk analysis but also from previous experience. I now need to document the testing and rather than start from a blank sheet of paper thought a template would speed things up.

Thanks for your input.

AliceW

Alice,
I am not sure what you mean when you say "product" validation... Did your company design the product? Are you manufacturing the product? What about surface finishing?