Checklist for Design Input items for Medical Devices wanted

[Rob Udo]

Does someone have a checklist for design input items for medical devices (just a list with items to consider while preparing your design input)?

Thanks,

Rob Udo

 

[Aaron Lupo]

Does someone have a checklist for design input items for medical devices (just a list with items to consider while preparing your design input)?

Thanks,

Rob Udo

Do you have a copy of the 13485:2003 and 14969 Standards? If so they pretty much spell out the types of things you should be looking for. In the mean time I will look and see what I have.

 

[Al Rosen]

As Aaron said, look at ISO 13485 7.3.2 Design and development inputs:

a) functional, performance, and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management (see 7.1).

It's pretty straight forward.

 

[JonLowe]

Re: Does someone have a checklist for design input items for medical devices?

So I know this is from a long time ago, but maybe someone will find this somewhat helpful in the future. I have attached a short checklist that needs to be expanded by someone who knows more about these things.

 

[Marcelo]

Re: Does someone have a checklist for design input items for medical devices?

Hello and welcome to the Cove!

Thanks for sharing.

Design inputs are nothing more than product requirements.

Another source of "types"of product requirements that I use is the diagram by Pugh that I attached in this post - https://elsmar.com/Forums/showpost.php?p=589847&postcount=9