M
In a separate thread, Ronen E interestingly commented:
I fully agree with this comment, and agree that such auditing is entirely sensible. However, it has interesting implications.
How does an auditor, on behalf of an NB, determine what is an "industry standard"? What would the substantiating reference be?
In particular: it's well known that for economic reasons, certain device types' predominant designs and clinical modes of operation are substantially based on what is most marketable in the US.
It's similarly well known that many device types' predominant designs and clinical modes of operation are thereby based on US FDA rules, guidances and expectations/demands in regard to what examiners will approve during the premarket review process.
So would an auditor of a 13485 / MDD quality system make reference, in an "industry-standards"-conformance finding, to FDA requirements?
If we just could get the FDA to reciprocate...another path to harmonization, anyone?
Please note that in some specific cases specific standards (usually device-specific or application-specific) are either mandated by legislation other than MDD, or well-established as "industry-standard" and therefore failure to comply may be quite difficult to justify.
How does an auditor, on behalf of an NB, determine what is an "industry standard"? What would the substantiating reference be?
In particular: it's well known that for economic reasons, certain device types' predominant designs and clinical modes of operation are substantially based on what is most marketable in the US.
It's similarly well known that many device types' predominant designs and clinical modes of operation are thereby based on US FDA rules, guidances and expectations/demands in regard to what examiners will approve during the premarket review process.
So would an auditor of a 13485 / MDD quality system make reference, in an "industry-standards"-conformance finding, to FDA requirements?
If we just could get the FDA to reciprocate...another path to harmonization, anyone?