Quality Risk Management Training Course ISO 14971 : 2019

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Our fully interactive Risk Management course provides attendees with all the knowledge and skills they need to comply with ISO 14971:2019 and Medical Device Regulations, such as the EU MDR and IVDR. The course is fully tutor led and focuses on the practical implementation of Risk Management from the standpoint of; design, manufacture, distribution, and use, right through to post-market feedback. The course involves practical exercises and group working with comprehensive feedback by the course tutor throughout.

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ISO 14971: 2019 – the Risk Management process and analysis of the requirements of the standard.
How to use EN ISO 14971:2019&A11:2021 (European Amendment Z Annexes) to comply with the EU MDR and IVDR.
ISO TR 24971:2020 and its relationship to ISO 14971: 2019 and the MDR/IVDR.
Understanding the difference between AFAP and ALARP.
Characterizing Medical Devices.
Identifying possible hazards.
Estimating the associated risk – removing subjectivity.
Risk Review and Risk Reduction.
Risk Management Techniques.
Practical Exercises on;
‒ Preliminary Hazard Analysis (PHA)
‒ FMECA
‒ HAZOP
‒ Fault Tree Analysis (FTA)
Application of Risk Management to Software Risks.
Using ISO 14971 to comply with the following standards;
‒ IEC 62304 (Software Development)
‒ IEC 62366 (Usability)
‒ ISO 10993 (Biocompatibility)
The Practical Implementation of ISO 14971.
Benefit-Risk analysis.
Risk Management Reporting.
Production and Post Production Information.
How to Determine the State-of-the-Art.
Disclosure of Residual Risk.
How to apply Risk Management to the Product Lifecycle.
End of Course Assessment

Anyone involved in the implementation of Risk Management for medical devices or anyone wishing to get a good practical grounding in the application of ISO 14971:2019 will greatly benefit from attending this course. This may include;

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

Participants in this course will be able to apply Risk Management techniques in compliance with ISO 14971:2019 and regulations such as the EU MDR and IVDR. Participants will gain the knowledge and skills necessary to document risk assessment outcomes in an audit-ready fashion.

Gerry Burke

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

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John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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Kevina O’Donoghue

Kevina takes great pride in the training she delivers. She unde...

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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.

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Snapshot

Online Learning FAQ >

Course Code

LS033

Duration

2 training days

Public Price

Virtual Training: €695

(includes course documentation).

Delivery Mode

This programme is delivered by Classroom, Virtual Training, or In-Company training

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News & Updates

Harmonisation of Z Annexes for ISO 14971:2019 in Q1 2022

The Z Annexes for ISO 14971:2019 have been published and will be Harmonised in Q1 2022. It has been a long two years since ISO 14971:2019 Medical Devices – Ap...

Is Analysis of Multiple-Fault Conditions a Requirement of ISO14971?

The above question was posed by one of the delegates at a recent Quality Risk Management and ISO 14971:2019 virtual training course delivered by our expert Tuto...

Medical Device Risk Management and ISO 14971:2019

Introduction

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Who should participate?

What will I learn?

Who are the tutors?