W
Hello everyone,
Our company is new to the world of medical device manufacturing and lots of questions and opinions are surfacing. I would love to hear your thoughts and insight on this one.
We are in the midst of planning design verification testing for our first product. One verification test will require us to run a gear reducer at changing speeds and directions for an extended period of time. The engineer wants to use a motor and programmable controller to switch between the different parameters. This test will only done for the initial verification, it will not be a test requirement for our production units. Is there a requirement in 21 CRF 820 or ISO 13485 to perform IQ, OQ, PQ on the verification test set-up? Thanks in advance.
Regards,
Jim
Our company is new to the world of medical device manufacturing and lots of questions and opinions are surfacing. I would love to hear your thoughts and insight on this one.
We are in the midst of planning design verification testing for our first product. One verification test will require us to run a gear reducer at changing speeds and directions for an extended period of time. The engineer wants to use a motor and programmable controller to switch between the different parameters. This test will only done for the initial verification, it will not be a test requirement for our production units. Is there a requirement in 21 CRF 820 or ISO 13485 to perform IQ, OQ, PQ on the verification test set-up? Thanks in advance.
Regards,
Jim