Advice on scope of my QMS - Company that has 2 products

keldez

Involved In Discussions
#1
Hello All,
So I've been asked as a consultant to set up a QMS for a company that has 2 products - one is MDDS imaging software/hardware, the other is up and coming Class 2 imaging software. This is all in the dental world, where consistent guidance from a notified body is very rare.
My task in more detail is to get whatever is necessary for regulatory compliance set up for the Class 2 software as a priority, as the MDDS product has decent design/process documentation already set up and running
My background is only with Class 2 hardware, so I'm quick to unleash ISO 13485/9001 and QSR 21 CFR and cover everything in one fell swoop under a comprehensive Quality Manual.
Even though I'm dealing with class 2 imaging software, doesn't this still qualify as a 'medical device', thus subjecting me to approach it comprehensively with ISO 13485, QSR, and ISO 62304 requirements where applicable and define "non-applications"?
In other words, I can't just take ISO 62304 and disregard ISO 13485? Comparable products in this industry have no Quality System to overblown Quality Systems. I would like to just do the minimum required, as logic would go.

Thank you
 
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keldez

Involved In Discussions
#3
Is the logic basically: Because it's a "Medical Device" ---> requires at least QSR compliance in US ---> requires QMS?
I'm using 13485 because the private label seller of the MDDS product wants some proof of compliance to 9001, so with the Class 2 product coming up, I figured it would save effort and just comply to 13485 for both products (with 9001 and 13485 being so similar). I've pretty much already drafted a QM with compliance to 13485 and QSR. I forgot to mention I have ISO 14971 considered as well.
Good to know the QMS is required - I will look into how/if this product applies to 62304.
The class 2 imaging software appears to apply mainly to Design Control, Complaints/CAPA, and Quality Plans etc. which is a good chunk of a hardware QMS (minus some Production, RI, and Infrastructure details) anyway. Would you define the exceptions for the class 2 software in its Device Quality Plan and keep the overall QMS generic (e.g. "if applicable....")?


Thanks for your help!
 
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