Hello everybody,
Medical Device Design Validation is a nice topic...
Everyone in here knows the following defintion:
"Design Validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions."
What does this mean in the daily business - at my site I often have problems to explain people the legal ways and possibilities for performing a design validation to be conform to §820.30g
So I come to my question: what are legally correct ways for performing a design validation (concerning medical devices class 1 and 2)?
Is it allowed to do a kind of "field testing" (user gets the verified product for e.g. 3 months to use it allone at home)??? - of course I am not talking about a clinical study (IDE,...) when I use the term field test.
In my opinion this way is not allowed - am I right?
Thank you very much for your support.
Best regards,
Aphel
Medical Device Design Validation is a nice topic...
Everyone in here knows the following defintion:
"Design Validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions."
What does this mean in the daily business - at my site I often have problems to explain people the legal ways and possibilities for performing a design validation to be conform to §820.30g
So I come to my question: what are legally correct ways for performing a design validation (concerning medical devices class 1 and 2)?
Is it allowed to do a kind of "field testing" (user gets the verified product for e.g. 3 months to use it allone at home)??? - of course I am not talking about a clinical study (IDE,...) when I use the term field test.
In my opinion this way is not allowed - am I right?
Thank you very much for your support.
Best regards,
Aphel
