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Hi all,
Thanks everybody for such a good collection of replies and documents. I just recently became the usability engineer of our team and it's been quite a challenge to understand everything that has to be done to comply with the regulations and develop sound products. If I might, here are my $0.02
Usability testing or engineering does not only refer to filling out a template, you HAVE TO test your device. Allow me to insist. If not for pure regulatory compliance, do it to demonstrate your professional ethics and values. All the products being designed here have the potential to hurt somebody, let's make sure they don't. Besides, it's really fun and interesting to put your product out in people's hands and learn how they interact with it. Always so many surprises.
To know how to run a usability test, reading the 62366 is not the best source, IMHO the standard actually doesn't help at all to learn how to run a usability test. There's just so much to running one (or several, depending how many your device's development process needs) of those tests.
There's a couple of FDA guidelines and presentations that do a good job explaining it and also a bunch of books. I've found the one written by Wilkund and the one by Rubin (already mentioned) to be the best ones out there. Read them and you'll have at least one foot on the right path.
I was really lost on how to actually document the UE File, but thanks to all of you who so kindly uploaded your samples. I wish the annex H had a little bit more explanation to it (or a better format), but mostly everything got cleared up when I read annex A. If you're still confused about what everything means, go read annex A.
I'll now go and write my own version of the UE File for my products, and add it to our product history file (where our risk management file lives). I hope this will put us in line with the FDA requirements.
Cheers!
Thanks everybody for such a good collection of replies and documents. I just recently became the usability engineer of our team and it's been quite a challenge to understand everything that has to be done to comply with the regulations and develop sound products. If I might, here are my $0.02
Usability testing or engineering does not only refer to filling out a template, you HAVE TO test your device. Allow me to insist. If not for pure regulatory compliance, do it to demonstrate your professional ethics and values. All the products being designed here have the potential to hurt somebody, let's make sure they don't. Besides, it's really fun and interesting to put your product out in people's hands and learn how they interact with it. Always so many surprises.
To know how to run a usability test, reading the 62366 is not the best source, IMHO the standard actually doesn't help at all to learn how to run a usability test. There's just so much to running one (or several, depending how many your device's development process needs) of those tests.
There's a couple of FDA guidelines and presentations that do a good job explaining it and also a bunch of books. I've found the one written by Wilkund and the one by Rubin (already mentioned) to be the best ones out there. Read them and you'll have at least one foot on the right path.
I was really lost on how to actually document the UE File, but thanks to all of you who so kindly uploaded your samples. I wish the annex H had a little bit more explanation to it (or a better format), but mostly everything got cleared up when I read annex A. If you're still confused about what everything means, go read annex A.
I'll now go and write my own version of the UE File for my products, and add it to our product history file (where our risk management file lives). I hope this will put us in line with the FDA requirements.
Cheers!