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Possible Revision of ISO 13485:2016

For those that work in the medical devices sector ISO 13485:2016  - Medical devices – Quality management systems – Requirements for regulatory purposes is an important standard.

It ensures that manufacturing quality focuses on development of safe and effective medical devices.

The standard is also recognised and used in support of medical device regulation at a global level.


Opportunity for Irish stakeholders to have your say:

The international group that developed this standard (ISO/TC 210/WG1) are seeking stakeholder feedback on the existing use of the standard for regulatory purpose. The aim is to gauge stakeholder needs with respect to regulatory use and possible changes that are needed.

Irish stakeholders from the medical device industry are encouraged to provide their feedback on the use of the standard and whether or not any change is needed.  Providing feedback will ensure Irish stakeholders inputs are considered by the drafters of this standard.


The survey is available here, with a closing date of December 31st, 2023.


Interested in keeping up to date on standard development? Consider getting involved in standard development – see NSAI Standard Committees in the Healthcare and Lifescience area.