What are the changes in EN ISO 13485:2003/AC:2009 ?

C

chloep17

I work within the Regulatory department of a Medical Device manufacturer and am looking to find the general consensus on compliance with Amended Corrigenda. We have been informed by our Notified Body that they do not require stated compliance with EN ISO 13485:2003/AC:2009 even though this is the most up to date version.

Any advice or information on how everyone else deals with this would be greatly appreciated.
:thanx:
 
Ajit Basrur

Ajit Basrur

Leader
Admin
chloep17 said:
I work within the Regulatory department of a Medical Device manufacturer and am looking to find the general consensus on compliance with Amended Corrigenda. We have been informed by our Notified Body that they do not require stated compliance with EN ISO 13485:2003/AC:2009 even though this is the most up to date version.

Any advice or information on how everyone else deals with this would be greatly appreciated.
:thanx:
Click to expand...

Welcome to the Cove :bigwave:

You can refer an existing thread - ISO 13485:2003 / Corrigendum 1:2009 has been published - Free!
 
C

chloep17

Thank you for this.

However it doesn't answer my query of what we should state we are compliant to: ISO 13485:2003 or ISO 13485:2003/AC:2009.
 
C

chloep17

We've seen certification on the web that companies are now being registered by their notified body to the ISO 13485:2003/AC:2009, with this in mind, as a medical device manufacture should we not be showing the AC references in our compliance to the ERs.
 
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