Looking for an ISO 13485 Certified Body in the US

Luisiso · Jan 12, 2015

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

DannyK · Jan 12, 2015

Re: Looking for a Certified Body

Are you looking for CMDCAS certification or CE marking as well?

AndyN · Jan 12, 2015

Re: Looking for a Certified Body

Luisiso said:
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: Are you seeking a "notified body" to submit your medical device to, or a certification body, to perform ISO 13485 certification? IAS is an accreditation body, which isn't the same as a notified body or a certification body.

My organization can certify you to ISO 13485. WWW.NQA-USA.com

dsanabria · Jan 13, 2015

Luisiso said:
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

http://www.abs-qe.com

http://www.asrworldwide.com

http://www.bsiamericas.com

http://www.us.bureauveritas.com

http://www.dnvba.com/us/Pages/default.aspx

http://www.intertek-sc.com

http://www.lrqausa.com

http://www.nqa-usa.com

http://www.nsf-isr.org

http://www.orion4value.com

http://www.pjr.com/

http://www.sriregistrar.com

http://www.saiglobal.com

http://www.tuv.com

http://www.tuvamerica.com

http://ul-dqsusa.com/

Hope this helps and keep us posted.

Luisiso · Jan 13, 2015

Re: Looking for a Certified Body

Andyn,
I am looking for a certification of body so my business can receive an ISO 13485 certification.

Luisiso · Jan 13, 2015

Re: Looking for a Certified Body

Are you experience working with OBL?. The product we sell is made by another company which is already ISO certified. We need to be shown as the manufacturer on the certification so will you accept the OEM's so certification so only our office is audited?

dsanabria · Jan 13, 2015

Re: Looking for a Certified Body

Luisiso said:
Andyn,
I am looking for a certification of body so my business can receive an ISO 13485 certification.

read post #4

Reg Morrison · Jan 13, 2015

Re: Looking for a Certified Body

dsanabria said:
read post #4

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.

AndyN · Jan 13, 2015

Re: Looking for a Certified Body

Luisiso said:
Are you experience working with OBL?. The product we sell is made by another company which is already ISO certified. We need to be shown as the manufacturer on the certification so will you accept the OEM's so certification so only our office is audited?

You can be certified to ISO 13485 as a distributor of the device, manufactured by someone else. Your scope will appear on your certificate and it will clearly identify you're NOT the manufacturer, but a re-seller or distributor.

Luisiso · Jan 13, 2015

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.

Looking for an ISO 13485 Certified Body in the US

Luisiso

DannyK

AndyN

Moved On

dsanabria

Quite Involved in Discussions

Luisiso

Luisiso

dsanabria

Quite Involved in Discussions

Reg Morrison

AndyN

Moved On

Luisiso

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