DRDDO
27th February 2009, 06:20 AM
Dear All
Did anyone know about ISO 13485:2004?
:thanx:
DRDDO
Did anyone know about ISO 13485:2004?
:thanx:
DRDDO
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View Full Version : Does anyone know about ISO 13485:2004? harry 27th February 2009, 06:36 AM UNE-EN ISO 13485:2004 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) UNE-EN ISO / 12-Mar-2004 / 70 pages This product has a corrigendum: UNE-EN ISO 13485:2004 ERRATUM , UNE-EN ISO 13485:2004 ERRATUM:2007 JCVP1969 27th February 2009, 06:52 AM Hi DRDDO, I have been working in this field since 1997 in both medical devices and in-vitro diagnostic medical devices. What would you like to know as it is quiet a broad question you have asked there! Kind regards JCVP Ajit Basrur 27th February 2009, 09:31 AM Dear All Did anyone know about ISO 13485:2004? :thanx: DRDDO In addition to Harry answer, it is an EN standard that is identical to ISO 13485:2003. DRDDO 27th February 2009, 12:57 PM Hi DRDDO, I have been working in this field since 1997 in both medical devices and in-vitro diagnostic medical devices. What would you like to know as it is quiet a broad question you have asked there! Kind regards JCVP I found one supplier in China, declare ISO 13485:2004 certified, I only want to make sure that supplier do not lie me Thanks DRDRO JCVP1969 27th February 2009, 01:27 PM Hi again, Get a copy of his Certification, it should be by a recognised Certification Body. If it is not then it is unregulated. Also if they are stating their product conforms to ISO 13485 then that is not right as they are not allowed to do that. The company is certified to ISO 13485 and not the product. If it is a medical device the requirements will differ depending on where you are. In Europe it will need to be CE Marked and in USA it should have some sort of FDA approval such as a 510(k) Ajit Basrur 27th February 2009, 08:24 PM I found one supplier in China, declare ISO 13485:2004 certified, I only want to make sure that supplier do not lie me Thanks DRDRO Interesting ! Get a copy of his ISO 13485 certification for verification. Hi again, Get a copy of his Certification, it should be by a recognised Certification Body. If it is not then it is unregulated. Also if they are stating their product conforms to ISO 13485 then that is not right as they are not allowed to do that. The company is certified to ISO 13485 and not the product. If it is a medical device the requirements will differ depending on where you are. In Europe it will need to be CE Marked and in USA it should have some sort of FDA approval such as a 510(k) Yes, I agree with you :) DRDDO 28th February 2009, 10:16 AM Interesting ! Get a copy of his ISO 13485 certification for verification. Yes, I agree with you :) I will do as both of you advice and let you know the status, :thanx: DRDDO |
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