Looking for an ISO 13485 Certified Body in the US

[AndyN]

Re: Looking for a Certified Body

Andy,
This is not what I have been told. The OBL is the legal manufacturer according to the medical directive so we need to be shown as such.

OK, I will double check, however, I am fairly certain that a) a distributor CAN be ISO 13485 certified and b) you don't HAVE to be the manufacturer.

Sadly, there are some folks who - without any real knowledge - give "opinions". I quote clients daily for ISO 13485 - and they aren't all manufacturers...

 

[Statistical Steven]

Re: Looking for a Certified Body

Sadly, there are some folks who - without any real knowledge - give "opinions".

Andy that is the issue with Bulletin Board such as the Cove. Too many give opinion as fact and there is NO way to separate the BS from the facts.

 

[AndyN]

Re: Looking for a Certified Body

Andy that is the issue with Bulletin Board such as the Cove. Too many give opinion as fact and there is NO way to separate the BS from the facts.

I got the impression from the OP they had been told, someplace else, not here...

 

[MIREGMGR]

"Distributor" and "own brand labeler" are not equivalent terms under EC rules.

We need to be shown as the manufacturer on the certification

The OBL is the legal manufacturer according to the medical directive so we need to be shown as such.

If your name will appear on the label as the company responsible for the marketing of the product, even though you do not physically fabricate that product, then you need to be the OBL. It sounds from the quotes above as if that's what you're after.

If on the other hand you merely wanted to sell the product, and it was fine with you that the product was labeled with the actual maker's name (or someone else's name), then you could be a distributor.

 

[dsanabria]

Re: Looking for a Certified Body

According to the ANAB database, there are 14 registrars accredited to ISO 13485. Your list shows 16. So, there are at least 2 which are not accredited to issue ANAB accredited ISO 13485:2003 certificates.

Careful in reading ANAB sites....

ANAB will disqualify a registrar for financial, a non conformance or unable to do a site audit.


They don't have to justify why it is done and the reason.

The best way is to go directly to the registrar and talk to them.

Hope this helps!

 

[Luisiso]

I do not want to be the distributor. We want to be the manufacturer and according to the European regulatory authorities we are the legal manufacturer. I am not sure why I got so many mixed answers about this. It is stated every where that the person who put the product on the market is the legal manufacturer period..

 

[Luisiso]

Re: Looking for a Certified Body

Andy, I want to be the manufacturer and in fact we are because we are putting this product under our name. It is called OBL or PLM..

 

[dsanabria]

I am looking for a certified body who can certificate my business with ISO 13485. How can I tell is a CB is a reputable one?. My consultant recommended me IAS (international accredited Service), does anyone here knows this CB?. Cna someone recomend me a good reputable CB in the USA.. Any advise would be very appreciated..


Thank you,

Luis

Luis

OK - Please slow down and tell the cove member what you are thinking and hope that you are getting because i did noticed a slight misunderstanding into what you are thinking / wanting / desiring and expecting...

 

[AndyN]

Re: Looking for a Certified Body

Andy, I want to be the manufacturer and in fact we are because we are putting this product under our name. It is called OBL or PLM..

"Want to be" and "are" are two different conditions. To have "manufacture of medical device X" in your ISO 13485 scope, you HAVE TO BE ACTUALLY MANUFACTURING X.

If you aren't doing this right now, is it your plan to take over the manufacturing? You cannot be certified to ISO 13485 until you have implemented a management system, with history of the manufacturing process. I'm sure someone will add in the relevant details about who "owns" the device files (such as the 510K for example)

Before you become overly concerned about selecting a CB, it sounds like you have some work to do...(unless you aren't giving us the whole story)

 

[MIREGMGR]

Re: Looking for a Certified Body

To have "manufacture of medical device X" in your ISO 13485 scope, you HAVE TO BE ACTUALLY MANUFACTURING X.

I think I know why you say this, but my view would be that it's misleading. On the other hand, LuisISO's statement above about being a PLM is in need of further discussion.

Generally, the "OBL" concept as a regulatory status exists only in the EC. In USA, for instance, there is no parallel status. FDA's "private label" status applies to distributors, not manufacturers/specification providers. But within EC, in order to be eligible to put a medical device on the market under your own name, generally you need to have a QMS already in place (of course, this is the topic of your original post), and generally you will apply your own CE Mark to the product. If you don't yet have those capabilities in place, you probably aren't an OBL in legal fact, yet.