Quality Training
ISO 13485:2016
Objectives
To understand the Medical Devices Quality Management System ISO 13485:2016Content 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 IndustryUpcoming dates:
No training dates available at the moment.
Register your interest
Register your interest
Course
ISO 13485:2016
Training Days
1 day
Training Locations
Cork, Galway, Limerick, Online
Course Cost
Subsidised rate: €120
Full cost: €160
* Cost quoted per person