Medical Device Risk Management and ISO 14971:2019

Master practical risk management for medical devices throughout the product lifecycle

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This two-day highly interactive training programme equips learners with a comprehensive understanding of ISO 14971:2019 and associated medical device regulations and practical skills for the application of risk management throughout the entire medical device lifecycle.

The course is delivered by our expert tutors and focuses on the implementation of Risk Management from the standpoint of; design, manufacture, distribution and use, right through to post-market feedback. The course covers compliance with the risk management requirements of EU MDR/IVDR and 21 CFR Part 820. The course involves practical exercises and group working with comprehensive feedback by the course tutor throughout.

We can tailor the training to meet your specific training needs and incorporate examples from your processes and procedures into the training programme as required.

This course blends theoretical knowledge with hands-on exercises to help learners implement risk management systems in line with ISO 14971:2019. It includes guidance on the application of related standards and practical tools for assessing and controlling risk.

Key topics include:

The ISO 14971:2019 risk management process
EN ISO 14971:2019 & A11:2021 (European Amendment Z Annexes) for MDR/IVDR compliance
Application of ISO/TR 24971:2020 guidance on ISO 14971
AFAP vs ALARP methodologies
Hazard identification and risk characterisation
Risk estimation – removing subjectivity
Risk reduction and risk control
Practical exercises in:
Failure Modes, Effects and Criticality Analysis (FMECA)
Preliminary Hazard Analysis (PHA)
Hazard and Operability Studies (HAZOP)
Fault Tree Analysis (FTA)
Risk management for software (IEC 62304), usability (IEC 62366) and biocompatibility (ISO 10993)
Determination of risk acceptability and application of the principle of State-of-the-Art
Benefit-Risk analysis and disclosure of residual risk
Collection, analysis and use of post-production data

The training involves practical exercises covering all relevant topics, with learners encouraged to work on examples from their own workplace as part of these practical exercises. If required, content may be tailored to reflect your organisation’s specific processes, risk profile and regulatory setting.

This course is ideal for anyone involved in the development, regulation, or quality assurance of medical devices. It supports those responsible for ensuring compliance with ISO 14971:2019 and, US or EU regulations.

This includes:

Quality, Engineering, Technical and Production personnel
R&D Managers and Engineers
Regulatory Affairs and Clinical professionals
Quality Auditors

Learners from across the medical device sector will benefit from practical examples and shared best practices.

A good standard of written and spoken English is important to engage effectively with this programme.

On successful completion of this course, learners will be able to:

Interpret and apply the ISO 14971:2019 standard within their organisation
Identify and assess medical device hazards using a range of risk analysis tools
Conduct risk analyses using FMECA, PHA, HAZOP and FTA methodologies.
Document risk assessments in an audit-ready format
Integrate risk management throughout the device lifecycle including post-production feedback
Align risk management practices with the EU MDR, IVDR and supporting standards
Communicate benefit-risk decisions and residual risk levels
Apply risk management techniques to software, usability and biocompatibility standards

These outcomes ensure learners return with practical skills and knowledge necessary to meet regulatory requirements and auditors’ expectations.

This course is delivered by highly experienced tutors with specialist knowledge of medical device quality systems. Each Tutor brings a wealth of experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through learner engagement, the use of hands-on exercises and personalised support.

Learners benefit from expert-led training and direct feedback throughout the course.

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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To consolidate learning and reinforce key concepts, learners complete a post-course assessment.

The assessment;

Checks understanding of the course content and practical scenarios
Assesses practical understanding and application
Is completed within one week of course completion

Successful learners will receive a Certificate of Achievement, in addition to their Certificate of Attendance

Our training methodology is highly interactive, combining theory with application to build confidence and capability. Learners participate in structured discussions, case studies and applied activities throughout the programme.

Our support includes:

Emphasis on hands-on application through practical exercises, case studies and group activities that reinforce key concepts and encourage active participation
Pre-training consultation for In-Company courses to tailor content to organisational needs
Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance.
Flexible delivery options to suit different needs:
Onsite or live virtual sessions tailored for teams
Scheduled virtual public courses for individual learners
Real-time support from expert Tutors

Class sizes are generally limited to 12-15 to support personalized learning and individual support.

Learners who complete this course often continue to deepen their skills in:

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Snapshot

Online Learning FAQ >

Course Code

LS033

Duration

2 training days

Public Price

Virtual Training: £620

(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...