Design & Development, Research and Innovation in the Medical Device framework

invitro_spain

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#1
Hello folks,

I have to describe in a 15 minutes meeting the differences between Design and development and Research and Innovation in relation to the ISO 13485 in particular and the Medical Device framework, in General.

In my opinion, R&D is a flexible process not regulated by the ISO 13485. However, the specifications during this phase will be the inputs for the Design process. In this case, I follow the Stage-gate model for example.

Some fresh ideas could help

:thanx:
 
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invitro_spain

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#4
Hi Sidney and Ajit,

Thank you very much for your help. The information included in your links was very useful for me. In my opinion, the Stage-gate model would be a good point to make a relation between Research and Design. I consider that it is important to create the requirements and analyse the risks early in the process before the design.

Thanks again
 
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