Hey!! :bigwave:

I have read some very good posting about Design Input!!:) I would greatly appreciate some help with a few of my questions..!! :rolleyes:

I have been reading about the Design Input documents that have been discussed over the weeks.. So I was now wondering about the specific Performance Criteria segment :confused:

Performance criteria for a medical device as a part of a Design Input would include the specifics of the device or just basically the parameters around the performance of the device that would be important for the end user?

How detailed does this part get? I read the guidelines by the FDA and they mention that the description should be unambiguous but that is quite ambiguous!! :(

If anyone here has come across the performance criteria to be listed for a design input please shed some light over this subject for me as I am :frust:

:) Thanks guys.. Posting this post with all these smileys was FUN!!

:thanx:

Device Geek,
I moved your post to this forum, so that you will get more relevant feedback specific to your situation. We have many members that are from the medical device sector and should be able to assist you.

It is possible to use just a bulleted list... Such as details on:
− strenght requirements − Material properties
− Range of motion or use − Limitations
− Limits of extension/flexion − Application to patient
− Fatigue life − Mating components
− Fixation method − Biocompatibility
− Materials − Target costs

Just describe how the device should work, what is it expected to do.

Hope that helps.

Scott

Wow!! That does help Scott!!

I am gonna work on this list and I will keep you posted on how much it helps me!! :)

I am gonna start working on these parameters as soon as I get home!!

That was a great start!! :)