RUO audits - CFR 820.22 and ISO 13485 8.2.4

regqual

Starting to get Involved
#1
We are a small (startup) US based company with an RUO product. Do we have to comply to quality audits - CFR 820.22 and ISO 13485 8.2.4?
 
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yodon

Staff member
Super Moderator
#2
I think some clarification is needed first. If you're strictly in research (and not using the 'prototypes' on humans) then you're probably not under design controls. If you're in a trial then you should definitely be under design controls.

You may notice how I cleverly avoided mention of audit. Audits are against the company and are broader than a specific product (and broader than products). If you're registered to 13485 then you would absolutely need an internal audit. If you have product on the market in the US (or even registered as a device manufacturer) then you'd be under 820 and would need an internal audit.
 

regqual

Starting to get Involved
#3
Hi Yodon, We are strictly an RUO at this time and no diagnostic. We are complying with several parts of 21CFR 820 and with that compliance to ISO 13485 as applicable. Do we need to have internal quality audits?
 

yodon

Staff member
Super Moderator
#4
Again, audits are based on the state of your company, not the state of a particular product. If your product isn't on the market in the US and you're not going for ISO registration, I don't see why an audit would be necessary. If you're not fully compliant with all of 820 and/or 13485, a full audit would be rather meaningless. If you do an internal audit of the parts that you're working under, you may get some good info on where to improve.
 
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