ISO 13485 Medical Devices – Quality Management Systems – Requirements for regulatory purposes

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ISO 13485 Medical Devices – Quality Management Systems – Requirements for regulatory purposes

I have noticed on training courses this year that the recent publication of EN ISO 13485:2012 (Medical Devices – Quality Management Systems – Requirements for Regulatory purposes) is causing some confusion.

ISO 13485 :2003 is still the global standard. This is due for revision sometime in 2015.

The EN version of the standard contains a revised foreward & revised Annexes ZA, ZB & ZC. This is to link the European harmonised version of the standard with the European Directives:
– Annex II & V of Directive 90/385/EEC Active Implantable Directive
– Annex II,V & VI of Directive 93/42/EEC Medical Device Directive, &
– Annex III,IV & VII of Directive 98/79/EC In Vitro Diagnostics Directive.
There is no text difference between ISO 13485:2003 & EN ISO 13485:2012.

Our next training course on ISO 13485:2003 & The Medical Devices Directives is on 22-23 May 2012 in Galway. Please contact jfeehan@sqt.ie or telephone 061 339040 if you would like us to reserve you a place.

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