Looking for ISO 13485 Design Input and Output Files - Templates/Examples

[lebedek]

Hello,
Anyone has an example/template for the design input and design output files?
Thanks,
Alexander

Moderator's note: I changed your title to be a little more specific for better responses - Coury Ferguson

 

[maxwell]

Here's some templates you will need to make them device specific. Hope it helps.

Best Regards
Jerrylee1

 

[kirtee]

Here's some templates you will need to make them device specific. Hope it helps.

Best Regards
Jerrylee1

Hi Jerry

The first stage of design control is the development of a design inputs document. It is also called customer requirement.

I am preparing Design input document for some medical device. Can you please send me the format or template of design input document?