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Hello,
I am new to quality systems. I am working with a start up and my task is to build the quality system.
I am using a software we bought that includes a template of the ISO 13485 and modifying to best fit our company. I have lots of questions, but the one that is at the top of my list is about using a vendors quality system as part of our quality system.
The main component of our device is software. We do not build software, and none of us are computer programmers. We have contracted a company that specializes in creating software for medical device companies. Their quality system appears to be rock solid.
I did some research and asked someone at the FDA if it was ok to rely on a vendor's QS. They said it was ok as long is it was part of our quality system and procedures.
My questions is: Where in the manual or system would I put this? would it be part of the Quality manual itself? or do I put it under a SOP?
I am not sure if this is the correct forum for this thread, so please move if needed.
Thank you,
GR
PS. We are building a mobile telemetry monitor from components that are already approved. We are outsourcing the creation of the software that is going to link everything.
I am new to quality systems. I am working with a start up and my task is to build the quality system.
I am using a software we bought that includes a template of the ISO 13485 and modifying to best fit our company. I have lots of questions, but the one that is at the top of my list is about using a vendors quality system as part of our quality system.
The main component of our device is software. We do not build software, and none of us are computer programmers. We have contracted a company that specializes in creating software for medical device companies. Their quality system appears to be rock solid.
I did some research and asked someone at the FDA if it was ok to rely on a vendor's QS. They said it was ok as long is it was part of our quality system and procedures.
My questions is: Where in the manual or system would I put this? would it be part of the Quality manual itself? or do I put it under a SOP?
I am not sure if this is the correct forum for this thread, so please move if needed.
Thank you,
GR
PS. We are building a mobile telemetry monitor from components that are already approved. We are outsourcing the creation of the software that is going to link everything.