Auditing and harmonization? Determining what is an "industry standard"

M

MIREGMGR

#1
In a separate thread, Ronen E interestingly commented:

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.
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? :D
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
For industry standards I would look to codes, regulations and, yes, the standards that we certify to. A company could subscribe to a service like KellerOnline or one of these sources to be informed of standards and changes to them.
 
M

MIREGMGR

#4
I think from Ronen E's post that the reference was to "industry standards" other than those defined by formal standards that are systematically linked to the MDD.

At least that was my interpretation of that post's wording.
 

mpfizer

Involved In Discussions
#5
can u please help , how do we know if a standard is harmonized or not ?? as per MDD

also is there a list of harmonized standards for medical devices?
 

Marcelo

Inactive Registered Visitor
#7
Please note that in some specific cases specific standards (usually device-specific or application-specific) are either mandated by legislation other than MDD...
A steam sterilizer which has to comply with standards in the pressure equipment directive, for example...this same device has to comply with standards of the EMC directive.

or well-established as "industry-standard" and therefore failure to comply may be quite difficult to justify
Generally, industry standards are standards (these can be information or documents, not necessarily standards developed by standards development institutuions) which, although not compulsory, are usually accepted by the industry as a good practice on the subject. These would be the case of any guidance document, from FDA or other reg agency.

So would an auditor of a 13485 / MDD quality system make reference, in an "industry-standards"-conformance finding, to FDA requirements?
They could do something like that, but not refering to the external requirements...he could audit the quality system and conclude that it fits the requirements of the MDD.

Just an other point on the subject, please take note of the attached "Order of consideration of technical standards in MDD" doc...this was based, if i remember correctly, in the EU regulations book.
 

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