S
Hi
First post on the forum, but have been lurking for a while.
Can anyone help me please regarding Test Method Validation?
I work for a design consultancy and we've been developing a medical device for a client. We've produced devices for verification testing and will now be doing the verification testing in house.
Our client is of the opinion that we need to validate all our test methods - can anyone give me some advice on where to start please? The tests are mainly mechanical - force & torque to operate, pressure to move, sealing pressure, dose delivery accuracy etc.
How do you validate a mechanical lab test? We tried getting a series of technicians to test the same parts repeatedly, but the nature of what we are testing, means there is significant variability - so we can't show that different operators get the same results from the same test samples.
many thanks
Steve
First post on the forum, but have been lurking for a while.
Can anyone help me please regarding Test Method Validation?
I work for a design consultancy and we've been developing a medical device for a client. We've produced devices for verification testing and will now be doing the verification testing in house.
Our client is of the opinion that we need to validate all our test methods - can anyone give me some advice on where to start please? The tests are mainly mechanical - force & torque to operate, pressure to move, sealing pressure, dose delivery accuracy etc.
How do you validate a mechanical lab test? We tried getting a series of technicians to test the same parts repeatedly, but the nature of what we are testing, means there is significant variability - so we can't show that different operators get the same results from the same test samples.
many thanks
Steve
