Bicompatibility Evaluation Plan for Dental Devices

arora297

Registered
Hi,

Does any body has any expereince in developing a Biocompatibility Evaluation plan for dental devices?
If yes, please share your inputs.

Many Thanks,
 

yodon

Leader
Super Moderator
I don't, but I know the FDA is taking more interest in dental devices so you'll want to ensure you're on solid ground. You should probably (at least) look at the ISO 10993 family to see what might be relevant. You might also talk to some biocompatibility test labs to get their take (which, of course, will be to sell some test services, but they're generally going to give sound advice - you can competitively bid it to see how well recommendations align).
 
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