Quality Risk Management Training

ISO 14971:2019 was published in December 2019. The changes in ISO 14971:2019 involve the addition of a number of clarifications such a definition of ‘Benefit’ for the first time. The new standard also refers to Cyber Risks for the first time. Most of the guidance formerly contained in ISO 14971:2007 has been moved to its companion guidance document ISO TR 24971. Medical Device manufacturers are advised to use ISO TR 24971 in conjunction with ISO 14971:2019 as the basis of their Risk Management system. ISO 14971:2007 has been withdrawn and Medical Device manufacturers can expect the normal three-year transition period for compliance with the new standard.

ISO 14971:2019 has been designed to align more closely with international and national medical devices regulations such as the EU MDR 2017/745 and EU IVD MDR 2017/746 and makes reference to terms such as “State of the Art” (including and definition) and “As far as possible (AFAP)”. However, ISO 14971:2019 has been decoupled from the EU MDR harmonization process and was published without the usual Z Annexes. This means that EN ISO 14971:2012 still remains the appropriate standard for Risk Management for CE Marked Medical Devices.

The implications of the new standard and associated guidance and the changes required in order to achieve Risk Management compliance for EU and non-EU markets will be made plain by this informative one-day course on ISO 14971:2019. The course covers the regulations governing Risk Management for Medical Devices and the practical implementation of Risk Management from design, manufacture, distribution and use, through to post market feedback.

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ISO 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 Post Production 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.

R&D Managers and Engineers
Quality / Engineering / Technical / Production personnel
Quality Auditors

Participants achieve the following learning outcomes from the programme;

List the updated requirements of ISO 14971: 2019.
List the main contents of ISO TR 24971.
State the requirements for Risk Management for CE Marked Medical Devices.
State the relationship between ISO 14971:2019 and EN ISO 14971:2012.
Identify the correct use of the AFAP and ALARP approaches.
Identify and quantify risks associated with Medical Devices.
Apply various risk assessment techniques such as FMECA, Fault Tree Analysis and HAZOP.
Describe how to perform Benefit-Risk analysis.
State the requirements for Production and Post Production information
State the requirements for Disclosure of Residual Risk.
Describe the Life Cycle Approach to Risk Management.

In-House Courses

For In-House courses the tutor will contact you in advance to discuss the course programme in more detail in order to tailor it specifically for your organisation.

Course Manual

Delegates will receive a very comprehensive course manual.

Gerry Burke

Gerry is a self-motivated medical industry professional with kn...

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John Lafferty

John Lafferty, B. Tech. in Manufacturing Technology, Six Sigma ...

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Kevina O’Donoghue

Kevina O’Donoghue is a PhD graduate of the National Universit...

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