Quality Training

ISO 13485:2016


To understand the Medical Devices Quality Management System ISO 13485:2016

Content includes

Provide an insight to the use of ISO13485 as the basis for a Quality Management system implemented by medical device manufacturers
  • Review the requirements of ISO13485 and make comparisons to ISO9001:2012 and 13485:2012
  • Give participants an understanding of ISO13485 and its alignment to FDA’s Quality System Regulation
  • Assist participants in the relationship between ISO13485 and ISO14971- Application of risk management to medical devices
  • Identify what ISO13485 requires and also what is not required within the standard
  • Clarify process management in the context of the requirements of ISO13485
  • Give basic audit techniques in meeting the ISO13485 requirements.

Who should attend

Personnel working in the Medical Technology Industry

Upcoming dates:

No training dates available at the moment.

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ISO 13485:2016

Training Days

1 day

Training Locations

Cork, Galway, Limerick, Online

Course Cost

Member: €120
Non-member: €160
* Cost quoted per person

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