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Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili
This is realy obvious! Only the use of the MD will show if project is well done, but every designer know that the immagination of the stupid overtake the intelligence of the engeener, so the user will find a way to use the device in the incorrect way!
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I'm not 'so illuminated'. The Standard can help you to check your project respect the principal hazards, but 'the uncorrect use' is an more difficult proble to manage. In this way is necessary the experience of the designer who knows how the MD device works, who knows the basic knowledge of the standar user etc.
In brief, to prevent an incorrect use is a vary hard task, it is the first goal of the post market surveillance.
The regulations require that the manufacturer detect possible incorrect uses BEFORE putting the device into market. The experience with the use will show, among other things, if you were successful in this previous detection, or if you have to change your design due to not detecting.
If you are so illuminated as to not need to consult a document which aims to help manufacturers implement their processes, congratulations, but i think the majority of manufacturers usually find the documents very useful.
I'm not 'so illuminated'. The Standard can help you to check your project respect the principal hazards, but 'the uncorrect use' is an more difficult proble to manage. In this way is necessary the experience of the designer who knows how the MD device works, who knows the basic knowledge of the standar user etc.
In brief, to prevent an incorrect use is a vary hard task, it is the first goal of the post market surveillance.
