My question refers to any standard for medical product development. I just do not know in which of them my question is answered...
Is there a rule for filling test reports e.g. for verification or validation? I often fill out a word document and enter the test results electronlically. At the end this is printed and signed by me (tester).
Is that ok or am I supposed to write my comments and checkmarks and test results by hand and pen on the paper?
Thanks in advance
Frank
By the way: This question refers to European Medical Device Directive and also to FDA rules...
Is there a rule for filling test reports e.g. for verification or validation? I often fill out a word document and enter the test results electronlically. At the end this is printed and signed by me (tester).
Is that ok or am I supposed to write my comments and checkmarks and test results by hand and pen on the paper?
Thanks in advance
Frank
By the way: This question refers to European Medical Device Directive and also to FDA rules...

