Quality Risk Management & ISO 14971: 2019
ObjectivesThis 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 includesISO 14971: 2019 – detailed analysis of the requirements of the standard.
- 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.
- Estimating the associated risk – removing subjectivity.
- Risk Review and Risk Reduction.
- Understanding the difference between AFAP and ALARP.
- Risk Management Techniques Hazards - FMECA, Fault Tree Analysis (FTA), HAZOP and Preliminary Hazard Analysis (PHA).
- Benefit-Risk analysis.
- Risk Management Reporting.
- Production and Postproduction Information.
- Disclosure of Residual Risk.
- How to apply Risk Management to the Product Lifecycle.
- How to apply Risk Management to all aspects of Quality and Production.
Who should attend
15 September 2020