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ISO 13485 - Medical Device Quality Management System Standard - Page 2


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cdsco (central drugs standard control organization), india, iso 13485 - medical device qms, singapore health sciences authority (hsa), medical devices
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  Post Number #9  
Old 10th July 2010, 05:56 AM
xcanals_tecno-med.es's Avatar
xcanals_tecno-med.es

 
 
Total Posts: 84
Look! Re: ISO 13485 - Medical Device Quality Management System Standard

Hi all
See the new list of harmonized standards for the medical devices directives published in the Official Journal of the European Union on 7 july 2010

http://eur-lex.europa.eu/LexUriServ/...15:0044:EN:PDF

including the harmonization for the
EN ISO 13485:2003/AC:2009

So the quality manuals and certificates must refer now compliance to:

EN ISO 13485:2003 and EN ISO 13485:2003/AC:2009

or as usually abbreviated:

EN ISO 13485:2003+/AC:2009



Regards

Xavier
Thank You to xcanals_tecno-med.es for your informative Post and/or Attachment!

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  Post Number #10  
Old 19th September 2011, 10:30 AM
Leeshu

 
 
Total Posts: 4
Re: ISO 13485 - Medical Devices Standard

I am beginning to work with a Medical Device company that will provide devices in kits for specific uses i.e ER, or Dr. offices. They will not manufactrue, only assemble in kits and sold. There is an ISO standard 1345. Does anyone have any specific experiences with this standard?
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  Post Number #11  
Old 16th December 2011, 10:40 AM
htquality

 
 
Total Posts: 43
Re: ISO 13485 - Medical Device Quality Management System Standard

Hello all Covers -
An auditor (consultant doing one of our internal audits) pointed out that our external standards list should refernece EN ISO 13485:2003/AC:2009 and not ISO 13485:2003. I am a little confused with all the prefixes but if we have ISO 13485:2003 and the 2009 Technical Corrigendum 1, can we put "EN ISO 13485:2003/AC:2009" on our standards list (as I understand ISO 13485:2003/AC:2009 is the same as ISO 13485 + 2009 Corrigendum) or if we have to buy EN ISO 13485:2003/AC:2009 to comply?
Any clarification would be appreciated!
  Post Number #12  
Old 17th December 2011, 02:47 PM
xcanals_tecno-med.es's Avatar
xcanals_tecno-med.es

 
 
Total Posts: 84
Let Me Help You Re: ISO 13485 - Medical Device Quality Management System Standard

Dear all

For the European medical devices directives a list of harmonized standards is published in the Official Journal of the European Union, see here the publication history:

http://www.tecnologias-sanitarias.co...tiva/index.htm

note that the las published on 19 aug 2011 includes the harmonization for 2 standards:
- EN ISO 13485:2003 (ISO 13485:2003) and
- EN ISO 13485:2003/AC:2009 (ISO 13485:2003/cOR 1:2009)

So the quality manuals and certificates must refer now compliance to:

EN ISO 13485:2003 and EN ISO 13485:2003/AC:2009

or as usually abbreviated:

EN ISO 13485:2003+/AC:2009

The EN versions are the ISO version but including the annexes ZA, ZB and ZC which establishes the Essential Requirements of the medical devices directives covered by the standard

Regards

Xavier Canals-Riera
Thank You to xcanals_tecno-med.es for your informative Post and/or Attachment!
  Post Number #13  
Old 19th December 2011, 09:00 AM
htquality

 
 
Total Posts: 43
Re: ISO 13485 - Medical Device Quality Management System Standard

Thank you Xavier. So if I understand your response correctly, we do need to have a version that includes annexes ZA, ZB, and ZC (which are not in our current ISO 13485:2003 + Corr 1:2009)?
  Post Number #14  
Old 29th June 2012, 05:13 AM
wsong0808

 
 
Total Posts: 3
Approved Microbiologist for Medical Device

Hi,

I just joined a medical OEM and we were informed by our counterpart from India that we would need to have an approved microbiologist to acknowledge on the micro test report that we will perform. Can anyone advise how can we validate that a person is an approved microbiologist and will not be rejected by CE auditor during our CE application ? My company will assemble ballon + cathether ( invasive ), any one can advise on the product level and process level quality control for invasive device.

Rgds,
WS Ong
  Post Number #15  
Old 29th June 2012, 08:23 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,023
Re: Approved Microbiologist for Medical Device

Quote:
In Reply to Parent Post by wsong0808 View Post

Hi,

I just joined a medical OEM and we were informed by our counterpart from India that we would need to have an approved microbiologist to acknowledge on the micro test report that we will perform. Can anyone advise how can we validate that a person is an approved microbiologist and will not be rejected by CE auditor during our CE application ? My company will assemble ballon + cathether ( invasive ), any one can advise on the product level and process level quality control for invasive device.

Rgds,
WS Ong
Welcome to the Cove, wsong0808

In India, the Indian FDA (CDSCO) have this concept of "Approved Microbiologist" or "Approved Chemist" or "Approved Pharmacist" wherein the individual has to appear for an interview and based on his proficiency, an APPROVED status is granted.

These individuals are important as they are the only ones who can sign on the documents as final approvers for batch records or certificate of analysis.

You will have to approach the nearest office of the Indian FDA from your facility location. I am sure your Indian colleagues would know of this.
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #16  
Old 1st July 2012, 08:43 PM
wsong0808

 
 
Total Posts: 3
Re: ISO 13485 - Medical Device Quality Management System Standard

Thanks Ajit for the response. If i get you right, the Indian FDA is the one to grant the approval on the candidate. Will there be any certificate which can prove the candiate is with approved status ? And any validity timeline for the approval status ?

My company is located in Malaysia. I will check with local ministry of health if the same is imposed.

I need to set up the QMS to get my company certified for the ISO9001/ISO13485 and our product with CE marking ( our product is class III under CE calssification ). Can anyone advise how should I go on this ?

Rgds,
WS Ong
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