Medical Device Risk Management and 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 pr... Read More

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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What's covered?

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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

Who should participate?

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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

What will I learn?

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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.

Who are the tutors?

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How do we train and support you?

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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.

Share this Programme

SnapshotSnapshot

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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            [0] => life-sciences
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What Our Learner's SayWhat Our Learner's Say

‘Excellent. Tutor very knowledgeable’
Padraic O’T.

‘John was an engaging presenter, got the concepts across well and focused on key areas’
Brajith S.

News & UpdatesNews & 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...

Read More

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...

Read More

Medical Device Risk Management and ISO 14971:2019

Duration: 2 days **
Hide
  • 23 - 24 Oct 2024
    Location: Virtual Book Date

Medical Device Risk Management and ISO 14971:2019

Duration: 2 days
Virtual Training: €695
Hide
  • 23 - 24 Oct 2024
    Delivery: Virtual Training
    Location: Virtual
    Book Date