Hi,
From a mdical devices perspective, I think that if we'll have a reliable database for "just" ISO13485, it would be a big step forward, and that step will become more and more significant over time. In fact, it may change the rules of the game.
First off, ISO 13485 is very prevalent as it is now. Even systems such as the USA one, which basically rely on a different requirement set (e.g. 21 CFR 820) are already endorsing ISO 13485 to an extent. The EC system is practically ISO 13485 based. AFAIK there are only a handful significant markets that "resist" ISO 13485, and are expected to continue to do so for long. Further, if such a database is available, one of the first logical steps in assessing a potential supplier would be checking whether they have a valid, "good" ISO 13485 cert. If no such DB is available for "competing" certificates, it's likely that over time clients would tend to be more comfortable with ISO 13485. True, commercial preference alone won't beat regulatory requirements, but I believe that given enough time authorities will also see the benefit and may eventually converge.
Perhaps I'm just naive.
As far as pharma goes, I don't think they have an ISO parallel for 13485. Some use 9001 enhanced by things like ICH guidelines, some modify 13485 itself. Additionally, pharma is historically more strongly regulated than medical devices, so regulations abound for it, and what we usually term as QMS is just their almost-century-old GMP, which is by now almost carved in regulatory stone, so to speak. I think CERTO will be useful mostly from the commercial aspect, less from the regulatory one. In that sense maybe the pharma industry won't benefit from it too much, except maybe when sourcing things like packages, production equipment and supporting services such as warehousing and shipping.
Cheers,
Ronen.
From a mdical devices perspective, I think that if we'll have a reliable database for "just" ISO13485, it would be a big step forward, and that step will become more and more significant over time. In fact, it may change the rules of the game.
First off, ISO 13485 is very prevalent as it is now. Even systems such as the USA one, which basically rely on a different requirement set (e.g. 21 CFR 820) are already endorsing ISO 13485 to an extent. The EC system is practically ISO 13485 based. AFAIK there are only a handful significant markets that "resist" ISO 13485, and are expected to continue to do so for long. Further, if such a database is available, one of the first logical steps in assessing a potential supplier would be checking whether they have a valid, "good" ISO 13485 cert. If no such DB is available for "competing" certificates, it's likely that over time clients would tend to be more comfortable with ISO 13485. True, commercial preference alone won't beat regulatory requirements, but I believe that given enough time authorities will also see the benefit and may eventually converge.
Perhaps I'm just naive.
As far as pharma goes, I don't think they have an ISO parallel for 13485. Some use 9001 enhanced by things like ICH guidelines, some modify 13485 itself. Additionally, pharma is historically more strongly regulated than medical devices, so regulations abound for it, and what we usually term as QMS is just their almost-century-old GMP, which is by now almost carved in regulatory stone, so to speak. I think CERTO will be useful mostly from the commercial aspect, less from the regulatory one. In that sense maybe the pharma industry won't benefit from it too much, except maybe when sourcing things like packages, production equipment and supporting services such as warehousing and shipping.
Cheers,
Ronen.
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). Otherwise it may become as annoying as the GMDN paid database. Rather, I think there should be some sort of fee for the certificate holders - in a way it's like a good, targeted advertisement.
