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ISO 14971:2019 Risk Management for Medical Devices and IVDs-Practical Application

Virtual Learning

Course Overview

ISO 14971:2019 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks associated with the identified hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s quality management system.

This virtual instructor-led two-day course presents the key foundations of the risk management process defined in ISO 14971:2019 and provides expert tips on how to navigate the process including review of TIR 24971:2020.

This course is highly interactive and includes practical instruction, case study exercises and a competency assessment.

This course also includes a self-paced two-hour ISO 14971:2019 overview eLearning module that must be completed prior to the start of the live instruction.

This course pairs well as a prerequisite to Design Controls for Medical Devices and IVDs (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify regulatory requirements for risk management:
    • European Regulation EU 2017/745 (EU MDR)
    • European Regulation EU 2017/746 (EU IVDR)
    • 21 CFR 820.30(g)
  • Identify requirements of key International Standards relative to risk management:
    • ISO 14971:2019
    • ISO 13485:2016
  • Recognize risk management definitions and principles
  • Identify how risk management affects quality management system practices
  • Recognize one method for the practical application of risk management principles


Who Should Attend
This course is vital for any medical device professional looking to expand their knowledge on comprehensive risk management processes and explain their interactions with the entire lifecycle of a medical device from conception to decommissioning and disposal.

Price: $1200.00

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Additional Recommended Courses

CQI & IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements

This virtual instructor-led CQI/IRCA accredited course provides learners with the skills and knowledge that have taken many ​experienced ​auditors ​decades ​to ​develop. This course is fundamental to achieving CQI/IRCA Lead Auditor status. ​During ​the ​course, ​learners ​will ​plan, perform, ​and ​report ​audits ​based ​on ​case ​studies ​that ​simulate ​internal, ​supplier, ​and ​third-party ​audits ​utilizing ​MDSAP ​audit criteria. ​Learners ​will ​participate ​in ​simulated ​auditing ​exercises ​that ​include ​planning and performing audit activities, ​evaluating ​audit ​evidence, and documenting audit findings.

The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for non-native English-speaking learners, and learners with disabilities).

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Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.

By the end of this course you should be able to:

· Describe the purpose of:

  • Quality management systems
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MDSAP Internal Auditor Training

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Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

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This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union In Vitro Diagnostic Regulation (EU IVDR).  The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning and conducting EU IVDR audits according to NSF’s formal, documented EU IVDR Audit Model.

This course includes a two-hour eLearning prerequisite module, EU IVDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key pre- and post-market requirements associated with EU IVDR – standard regulatory requirements that must be met by all In Vitro Diagnostic manufacturers wishing to do business in the EU regardless of IVD classification.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

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  • Plan an EU IVDR Audit
  • Document Nonconformities against EU IVDR requirements

Who should attend:

This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU IVDR, for managers of audit programs, and for anyone who will be the subject of or participate in an EU IVDR audit. Delegates should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.

Price: $1200.00