Our auditor told if we didn't have a patent we would have to do a validation or verification

[Adacus]

Our auditor told if we didn't have a patent we would have to do a validation or verification. Is this true

 

[indubioush]

All medical devices need to undergo verification and validation. If necessary, validation is performed through a clinical study.

 

[Watchcat]

I think something must be getting lost in translation here. As indubioush has noted, under ISO 13485, verification and validation are always required. What class is the device?

 

[Adacus]

Class 1 Devices but we don't own patents

 

[Watchcat]

This might be a legal matter specific to your country, having to do with patent protection, rather than ISO 13485 or medical device regulations.

Was this an auditor from an EU notified body?

Also, if your auditor is citing requirements, they should be actually citing them. That is to say, they shouldn't just be telling you that you are required to do this or required to do that. They should cite the specific section of a specific law, regulation, or guidance where the requirement can be found. You should not accept an audit report or findings without these citations, nor should you accept an auditing organization that sends out auditors who fail to provide them. IMO. Hopefully the EU will not be accepting such auditors and audit reports going forward, but time will tell. If medical device companies are willing to accept them, then that's on them.

 

[Ronen E]

I've never heard of a regulation or a standard in the medical devices field that ties - in any way - patents and verification or validation.

Which doesn't say that something of that kind doesn't exist somewhere!...

 

[Tidge]

Our auditor told if we didn't have a patent we would have to do a validation or verification. Is this true

Class 1 Devices but we don't own patents

I'm curious as to how this 'observation' came about. Having a patent is not the same thing as having design controls. In the US 21 CFR 820 is very likely exempting your class 1 device from design controls anyway.