Medical Device Risk Management

A course presented over 5 half days (2.5 days total) by Bijan Elahi

  • Summary
  • Schedule / Register
  • Course Overview
  • Course Outline

Medical Devices Risk Management (MDRM) is a progressively more prominent topic in the medical device industry. Expectations by Regulatory bodies of medical device companies in producing quality, logical and defensible risk management files is rising. It is incumbent on the medical device manufacturers to convince the regulatory bodies that the benefits of a medical device outweigh its risks. Convincing the regulatory bodies is especially difficult for complex medical devices.

MDRM is a disciplined systematic approach to the analysis, estimation, evaluation, and control of safety risks associated with medical devices. Application of formal MDRM techniques can predict and prevent serious harm to patients and losses to businesses.

This training course delivered worldwide provides a comprehensive coverage of topics that are needed for successful management of safety risks of medical devices in conformance with the international standard ISO 14971. The scope of risk management includes both product development, and post market risk management.

Upcoming Courses

Register and pay 30 days prior to the course commencement date to receive a 10% early bird discount. Or register a group of 3+ for a 10% group discount. Available for corporate training worldwide.


The course commences with the fundamentals of medical devices risk management, then builds upon the fundamentals, and teaches a practical, sensible and efficient way of performing medical devices risk management. The course includes multiple quizzes and hands-on workshops to deepen the learning, and create an engaging learning experience.

Topics such as medical device software risk management, benefit-risk analysis and complaint handling are also addressed in this course.

This course will benefit:

  • Practitioners of medical devices risk management– including systems risk managers, systems engineers, design engineers, manufacturing engineers, quality engineers, usability engineers.
  • Evaluators of medical devices risk management– including quality assurance, management, regulatory staff.
  • People with a need for general understanding of medical devices risk management– including clinical, marketing, packaging, toxicology, management.

Participants will not need prior knowledge or experience with medical device risk management, but experience in medical device development would be an advantage.

Course Method and Materials:

The training is delivered using a balanced combination of lectures on the theory, and hands-on workshops to practice the just-learned theory. The focus is on deep and lasting learning that delegates can take away and put to immediate use in their work places.

Delegates are provided with a substantial package of presentation materials, electronic templates, and a copy of the book “Safety Risk Management for Medical Devices” authored by the course facilitator and published by Elsevier Publishing under the brand Academic Press. The book provides step-by-step instructions for performing the work of medical devices risk management.

Some Key Questions:

  • What is the difference between cause, hazard, hazardous situation and harm?
  • How can we establish that risks of a medical device are reduced to as low as possible?
  • How can we show that the benefits of a medical device outweigh its risks?
  • How do we manage software risks?
  • How does risk management inform and influence biological evaluation of medical devices?
  • What is the connection between usability engineering and safety risk management?
  • How should we monitor production and post-production medical device information?
  • How should knowledge gained from production and post-production be rolled back into the medical devices risk management process?
  • How should medical devices risk management influence verification testing?
  • What strategies should systems engineering take to prepare for validation of risk controls?
  • What is the difference between risk control and mitigation?
  • How do we determine when to stop reducing risks?
  • What factors contribute to successful analysis of hazards?

Training Objectives:

At the conclusion of this course, delegates are expected to have developed a sound working knowledge of medical devices risk management in compliance with ISO 14971, and be ready to apply their knowledge to their projects in the workplace.

Higher levels of skill and performance in medical device risk management will be attained and subsequently improved through practice and experience.

Who Should Attend this Course:

This Risk Management for Medical Devices course is designed for professionals who are engaged in medical devices development and risk management, or who need to quickly come up to speed on the theory and methods of medical device risk management, and be able to produce the required documentation to support successful submission and approval of a medical device by Notified Bodies, or by Regulatory Agencies such as the U.S. FDA.

The course will also be of value to those who will not perform medical devices risk management, but are required to review and approve medical devices risk management artifacts.

Course Availability:

This course is available worldwide for public and on-site delivery (i.e. at client-provided facilities).

1. The Value Proposition for World Class Medical Device Risk Management

Proper risk management is a value-adding activity to medical device product development.  Efficient, intelligent and effective risk management ensures smooth product approvals, reduced field corrective actions, and achieves significant cost savings to the business.

2. Introduction to Medical Device Risk Management

  • Why do we need to do medical device risk management?
  • The benefits of medical device risk management
  • Safety as an emergent system property
  • History and origins of risk management
  • Safety constraints
  • Cybersecurity and safety risk management
  • Language of risk management
  • Hazard theory
  • Hazard Taxonomy
  • How to distinguish subtle concepts in risk management
  • Quiz

3. Medical Device Risk Management Standards

  • ISO 14971 – the central standard in medical device risk management
  • Requirements of ISO 14971
  • Connections of ISO 14971 to: IEC 60601-1, IEC 62366, IEC 62304, ISO 10993
  • ISO 10993 – Introduction
  • IEC 60601-1 – Introduction
  • IEC 62304 – Introduction

4. Medical Device Risk Management as a Value-Added Activity

  • Risk management contribution to the various lifecycles in product development

5. Medical Device Risk Management Activities and Artifacts

  • Risk management plan
  • Risk management report
  • RM file
  • RM process
  • Risk analysis

6. Foundations for Medical Device Risk Management

  • System types
  • Introduction to Vivio AED – the test bed for in-class workshops
  • Clinical Hazards List (CHL)
  • What it is
  • How to create it
  • Example
  • Workshop - Create a CHL
  • Risk estimation
  • Classic and advanced methods
  • Harms Assessment List (HAL)
  • What it is
  • How to create it
  • Example
  • Workshop - Create a HAL
  • Quiz

7. Medical Device Risk Management Tools and techniques

  • Fault Tree Analysis (FTA)
  • Introduction
  • FTA workflow
  • Example FTA
  • Mind Map
  • Introduction
  • Workflow
  • Example Mind Map
  • Workshop - Mind Map
  • Preliminary Hazard Analysis
  • Introduction
  • Workflow
  • Workshop - Preliminary hazard analysis
  • Failure Modes and Effects Analysis (FMEA/FMECA)
  • Introduction
  • Is FMEA risk management?
  • Relationship between FMEA and FTA
  • Domains of Severity, Occurrence and Detectability
  • What does Severity mean?
  • What does Occurrence mean?
  • What does Detectability mean?
  • Risk management scaling via hierarchical-multi-level FMEA
  • FMEA cascade
  • DFMEA workflow
  • Workshop - DFMEA
  • PFMEA Introduction
  • PFMEA workflow
  • Workshop - PFMEA
  • Usability Engineering and risk management
  • IEC 62366 -- Introduction
  • Use/Misuse FMEA (UMFMEA)
  • UMFMEA Introduction
  • Use failure distinctions
  • How to distinguish reasonably foreseeable misuse
  • UMFMEA workflow
  • Workshop - UMFMEA

8. Software Medical Device Risk Management

  • Introduction
  • Software failure model
  • Language of SW risk management
  • Contribution of software to system hazards
  • Software risk
  • Examples of SW faults
  • SW risk management work flow
  • Software FMEA (SFMEA)
  • Software FMEA workflow
  • Software FMEA ground rules
  • Workshop - SFMEA

9. Medical Device Risk Assessment

  • Risk Assessment and Control Table (RACT)
  • Risk integration
  • RACT workflow
  • P1 and P2
  • Risk controls
  • Safe by design
  • Protective Measures
  • Information for safety
  • Risk controls end-point logic
  • Quiz
  • Verification of risk controls
  • Residual risk
  • Boolean algebra and quantitative risk computation
  • Workshop - RACT
  • Traceability

10. Benefit-Risk Analysis

  • FDA guidance
  • Criteria for benefit-risk analysis
  • FDA decision-making factors
  • Workshop - Benefit-Risk Analysis

11. Post market Medical Device Risk Management

  • Listening systems
  • Surveillance
  • Complaint handling
  • Assessment of production and post-production information
  • Update to the risk management file from post market data

12. In Closing

  • Medical Device Risk management as a team effort
  • Challenges with doing medical device risk management
  • Common mistakes in medical device risk management
  • Tips and wisdom for success.
Course Presenter

Bijan Elahi is an expert on a world scale in risk management & systems engineering. He was presented with Educator of the Year Award by the International System Safety Society and others in Medical Device System Safety.  LEARN MORE

Corporate Training

PPI offers all public training courses on-site, worldwide and has a range of specialist on-site only courses. Wherever your company is based, PPI will come and upskill your engineering and project teams. LEARN MORE

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