IS0 13485 - Design perspective to regulatory requirement.

[deepikanegi]

From a design perspective, if an auditor determines that the organization is subject to regulatory requirements, such as FDA 21 CFR Section 820, and has medical devices that required 510(k) clearance to demonstrate safety and effectiveness of a device before it is introduced into interstate commerce in the US, what he would ask?

 

[Enternationalist]

There's a lot to unpack here - basically, this question is unanswerable and doesn't really make sense unless we know the actual context. What are you actually trying to do?

First of all, auditors audit to something - so the answer depends on what auditor. Is it an ISO 13485 Auditor? Then they're not going to audit you to FDA requirements. At most, they'll suggest that you should consider those requirements.

An MDSAP Audit with the USA in scope? It covers FDA requirements, and you'd be held to those requirements. You could be asked about any part of them.

By "from a design perspective", I'm not sure what you mean. 21 CFR 820 is a quality system regulation.

Unless you can provide more detail on what you're trying to accomplish, I would recommend looking at the MDSAP Audit model. It's available online, and is used to audit to 13485, 21 CFR 820 and some other regional requirements - probably the closest you'll get to seeing what a typical quality system audit might look at.

Now, putting the product into market is an entirely different beast from setting up a quality system. Anyone who sees that you've marketed a device without clearance is not going to be asking you audit questions, they'll be getting in contact with the authorities - knowing what an auditor would ask is irrelevant; have market clearance before you market your device.

 

[somashekar]

From a design perspective, if an auditor determines that the organization is subject to regulatory requirements, such as FDA 21 CFR Section 820, and has medical devices that required 510(k) clearance to demonstrate safety and effectiveness of a device before it is introduced into interstate commerce in the US, what he would ask?

Hello and Welcome.
The determination of regulatory requirements is the call of the organization and this depends if you intend to put your medical device in a perticular regulatory region. If design and development is your inclusion in your quality management system, then all the requirements of the clause 7.3 should be demonstrated. If 510(k) applies, then your records of design will also address the requirements of FDA 21 CFR, 820.30.
You would also have seen this Acceptance checklist in case 510(k) applies to you and you will have all your records. I hope I have answered you to some extent...

 

[QuickSpace]

From a design perspective, if an auditor determines that the organization is subject to regulatory requirements, such as FDA 21 CFR Section 820, and has medical devices that required 510(k) clearance to demonstrate safety and effectiveness of a device before it is introduced into interstate commerce in the US, what he would ask?

First, your question is a bit confusing, however, let me predicate the scenario:

Let' say you are planning to do a 510k, however, you are still in the design stage and intend to do a 510k later, meanwhile you have implemented your QMS as per 21 CFR 820, and the auditor will be looking into your design files are done inline with 21 CFR 820.30 requirements. However, 21 CFR 820 auditing doesn't happen unless it is an MDSAP audit or if it is an FDA inspection. You can always state in your Quality Manual that you are still in design stage and the device is yet to commercialize. That statement will act as evidence for you. Hope this clarifies. Reach out to me in case of any questions.

If you are commercializing, of course, your 510k clearance letter will be your evidence.