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Checklist for Design Input items for Medical Devices wanted
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Checklist for Design Input items for Medical Devices wanted
Checklist for Design Input items for Medical Devices wanted
Checklist for Design Input items for Medical Devices wanted
Checklist for Design Input items for Medical Devices wanted
Checklist for Design Input items for Medical Devices wanted
Checklist for Design Input items for Medical Devices wanted
Checklist for Design Input items for Medical Devices wanted
Checklist for Design Input items for Medical Devices wanted
Checklist for Design Input items for Medical Devices wanted
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Some Related Topic Tags
checklist or check sheet, design and development, design inputs and outputs, medical devices
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  Post Number #1  
Old 10th April 2006, 04:29 AM
Rob Udo

 
 
Total Posts: 46
Please Help! Checklist for Design Input items for Medical Devices wanted

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

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  Post Number #2  
Old 10th April 2006, 07:32 AM
Aaron Lupo's Avatar
Aaron Lupo

 
 
Total Posts: 908
Quote:
In Reply to Parent Post by 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
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.
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  Post Number #3  
Old 10th April 2006, 09:11 AM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,559
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.
  Post Number #4  
Old 3rd May 2017, 02:13 PM
JonLowe

 
 
Total Posts: 1
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.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: docx Medical Device Design Inputs Checklist.docx (34.2 KB, 167 views)
Thanks to JonLowe for your informative Post and/or Attachment!
  Post Number #5  
Old 3rd May 2017, 02:25 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,099
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.p...47&postcount=9
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
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