This programme is grant subsidised by Connected Health Skillnet.
Objectives
This one day course covers the regulations governing risk management for medical devices and the practical implementation of risk management from design through manufacture, distribution and use, through to post market feedback. The implications of the new standard ISO 14971:2019 and associated guidance and the changes required in order to achieve Risk Management compliance for EU and non-EU markets will be made plain during this course.
Content includes
- Detailed analysis of ISO 14971: 2019
- ISO TR 24971 and its relationship to ISO 14971: 2019.
- Risk Management for CE Marking of Medical Devices and the relationship between ISO 14971:2019 and EN ISO 14971:2012.
- Characterizing Medical Devices.
- Identifying possible hazards.
- Risk Review and Reduction.
- Understanding the difference between AFAP and ALARP.
- Risk Management Techniques Hazards - FMECA, FTA, HAZOP, PHA.
- Benefit-Risk analysis.
- Risk Management Reporting.
- Production and Postproduction Information.
- Disclosure of Residual Risk.
- How to apply Risk Management to the Product Lifecycle and all aspects of Quality and Production.
Who should attend
- R&D Managers and Engineers
- Engineering / Technical / Production personnel
- Quality Auditors
Dates
13 April 2021, 09.00 - 17.00
This programme is grant subsidised by Connected Health Skillnet.
Connected Health Skillnet is co-funded by Skillnet Ireland and network companies. Skillnet Ireland is funded from the National Training Fund through the Department of Further and Higher Education, Research, Innovation and Science. (www.connectedhealthskillnet.ie)