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


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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


You could use the QSR and disregard 13485. What is required by your customers?
Also, 62304 isn't mandatory, but a QMS is.


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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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