CharmaineK
Registered
Hi there,
My company currently has software on the market that is a non-medical device and thus has been developed outside the MDR framework. We are now in the process of developing a version of our software that we will have on the market as SaMD. It will have a very similar architecture to our non-medical software besides a few, slight additions.
As we now begin to step into the realm of international standards/QMS/MDR (possibly even FDA regulations) to transition our product to SaMD, I am beginning to wonder if it is at all necessary to transition completely? Could we have a non-medical device on the market that we continue to develop outside of the MDR (but most likely still within our soon-to-be-set-up QMS) and then, when it comes to our SaMD, we use full modules from our non-medical device directly as SaMD SOUP? Meaning our SaMD will then mostly consist of various different SOUPs.
As far as 62304 goes, I see that each SOUP will fall under the "generally available/not developed for a medical device" definition of SOUP. But then, at the same time the software will not necessarily be completely "unknown" as we will obviously be the manufacturer for all of the modules we take from the non-medical device software. It also won't be "legacy" software as we will continue to have this on the market and build/develop it (outside the MDR) alongside our SaMD (under MDR).
There are other reasons I am leaning towards the two products route (broader usage/non-specific audience for example) but I wanted to see if there were any additional precautions we should be taking (as a manufacturer) if we go down this SOUP route? Or can we just treat each module as SOUP as per 62304 and build our SaMD this way?
To clarify - we have spoken to our competent authority about both products and they do not have any objections to our non-medical device software being outside the MDR and likewise, to our SaMD being a medical device.
Thank you in advance for any help/advice
My company currently has software on the market that is a non-medical device and thus has been developed outside the MDR framework. We are now in the process of developing a version of our software that we will have on the market as SaMD. It will have a very similar architecture to our non-medical software besides a few, slight additions.
As we now begin to step into the realm of international standards/QMS/MDR (possibly even FDA regulations) to transition our product to SaMD, I am beginning to wonder if it is at all necessary to transition completely? Could we have a non-medical device on the market that we continue to develop outside of the MDR (but most likely still within our soon-to-be-set-up QMS) and then, when it comes to our SaMD, we use full modules from our non-medical device directly as SaMD SOUP? Meaning our SaMD will then mostly consist of various different SOUPs.
As far as 62304 goes, I see that each SOUP will fall under the "generally available/not developed for a medical device" definition of SOUP. But then, at the same time the software will not necessarily be completely "unknown" as we will obviously be the manufacturer for all of the modules we take from the non-medical device software. It also won't be "legacy" software as we will continue to have this on the market and build/develop it (outside the MDR) alongside our SaMD (under MDR).
There are other reasons I am leaning towards the two products route (broader usage/non-specific audience for example) but I wanted to see if there were any additional precautions we should be taking (as a manufacturer) if we go down this SOUP route? Or can we just treat each module as SOUP as per 62304 and build our SaMD this way?
To clarify - we have spoken to our competent authority about both products and they do not have any objections to our non-medical device software being outside the MDR and likewise, to our SaMD being a medical device.
Thank you in advance for any help/advice