QAengineer13
Quite Involved in Discussions
To run a design feasibility trial , what are the required documentation?
I would really appreciate any input
Thanks!
I would really appreciate any input
Thanks!
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What documentation is required for Design Feasibility trial?
- Thread starter QAengineer13
- Start date
Re: What documentation is required for Design Feasibility trial ?
Probably need a little more info. Are you planning on doing the feasibility trial on humans? Is the device strictly mechanical, electro-mechanical, contains software, etc.? What harm can come from using it?
If none of the above and you're strictly proving a concept to yourself (and you're not developing under design controls), then maybe nothing.
Probably need a little more info. Are you planning on doing the feasibility trial on humans? Is the device strictly mechanical, electro-mechanical, contains software, etc.? What harm can come from using it?
If none of the above and you're strictly proving a concept to yourself (and you're not developing under design controls), then maybe nothing.
D
dblnkl
I agree with yodon. The type of feasibility trial is dependent on many factors. The design feasibility study may be on the bench, in animals or in humans, or a combination of the preceding. It may be governed by the sponsor alone, by an IACUC ( for animal studies), by an IRB alone or by the FDA in combination with an IRB(s). For more feedback, you need to provide us with more details.
QAengineer13
Quite Involved in Discussions
Apologies for not elaborating on the feasibility trial study. This project is related to healthcare skin product like Band aid ,trail study on different construction of material and then evaluate their performance which would be bench tested on certain characteristic like the adhesiveness etc.
The trial is planned on coating machine where diffrent layers of raw material are coated . Hope this helps.
The trial is planned on coating machine where diffrent layers of raw material are coated . Hope this helps.
D
dblnkl
Thanks for the additional information. Sounds like you already have a general scheme laid out for your feasibility study. For general reference, you should pay close attention to GLP regulations (21 CFR Part 58) in the conduct of your bench studies and, since your product comes into contact with skin, you should review and prepare for meeting applicable sections of ISO 10993 (biocompatibility). And, of course, your design verification studies should demonstrate that your design meets the product requirements in your marketing spec.