ISO 13485:2016

Date: 8th March 2018
Time: 08:30 - 17:00
Duration: 1 Day
Venue: Castletroy Park Hotel, Limerick
Event details

ISO 13485:2016

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

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


For all queries on the event, please call the event organiser:
Michelle Reinecke-Quain, Tel: +353 61 431802

Per delegate: €120.00
(plus VAT)
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