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

[invitro_spain]

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

 

[Sidney Vianna]

Re: Design & Development, Research and Innovation

R&D and Design Process. Where the borders are? if you research (pun intended) the topic, you will find a number of threads on the subject.

 

[Ajit Basrur]

Yes, there is this thread that you will find it useful:

Early Research & Development - ISO 13485:2003 requirements Clarification

Btw, 15 minutes may be too short to present this voluminous topic

 

[invitro_spain]

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