The internationally accepted standard guideline for medical device risk management is the ISO 14971 standard. This 2.4-hour long course is based on the current ISO 14971:2007 edition. It has been designed to provide a concise but complete knowledge of medical device risk management to supplement readings of the 80-page standard and to initiate those who are new to the medical device industry. More focus has been given to explaining the use of key tools such as the Failure Mode and Effects Analysis (FMEA) and the Fault-Tree Analysis (FTA) to enable immediate application in ISO 14971 projects. This course offers a systematic methodology to comprehend medical device risk management and connects the vital elements of risk management methodologies for a more efficient application of principles. It also provides guidelines on how to conduct productive meetings to construct medical device risk profiles.
Why is this course essential to take?
Performing risk management is a regulatory obligation and is the underpinning tool for assessing medical device safety. Risk management is part of the design input requirements during product design & development. This means that risk control and hazard reduction measures must be included as key considerations in the final medical device design, as well as in verification and validation studies. Risk evaluation should occur continuously throughout the production and post-production processes.
An organised and methodical approach to understanding and applying the ISO14971 principles
This ISO 14971 course takes a business approach to medical device risk management. Business tools such as project management techniques are recommended to establish risk management team structures. This ensures an organisation-wide support and commitment to comply with the ISO 14971 requirements. The Failure Mode and Effects Analysis (FMEA) and the Fault-Tree Analysis are discussed in greater detail to clearly explain their applicability to medical device risk management.
Course materials and resources provided
This lecture is presented by Dr. Nealda Yusof, the course instructor. Here, she introduces the overall course content and learning objectives, including what you will accomplish at the end of this course.
This lecture explains that risk management is an integral part of medical device regulatory compliance. It briefly introduces the origins of risk management, its objectives and importance as a corporate strategy tool to control product failure. Some key definitions for harm, hazard and safety are covered, as well as basic examples of medical device risks. This lecture also contains Workshop #1 - Risk Management Communication Canvas.
This lecture goes deeper into explaining the objectives of the ISO 14971 standard. The ISO 14971 standard is gaining worldwide recognition as the de facto risk management framework for medical devices. It reveals that medical device risk management affects and is also influenced by various stakeholder requirements. This makes risk management a complex exercise for medical devices.
Risk/benefit analysis is one of the core requirements of the ISO 14971 standard. This lecture presents the sources of information indispensable to completing risk/benefit analysis appropriately. It provides an overview of the risk/benefit criteria to enable the release of medical devices into the market.
This quiz consists of 14 questions in the multiple choice format. These questions will test your knowledge of ISO 14971 learnt in this section.
This section will explain the roles and responsibilities of the risk management team. A multidisciplinary team effort is necessary to successfully complete a complex medical device risk management project. The team must comprise of people with the right skills, knowledge and influence. This section also contains the recommended team hierarchy for a medical device risk management project.
This lecture provides a brief overview on ways to gather team members and announce risk management projects. It is crucial to gain management support. So, presenting a structured and organised set of objectives is highly essential. This lecture also contains Workshop #2 - Company/Stakeholder Profiling.
Section 3.4 of the ISO 14971 standard requires that all medical device risk management activities must be planned. A plan provides a high-level roadmap of risk management activities and processes. This lecture provides an outline of a ISO 14971 plan. Risk management plan and project management templates are provided in the Resources tab.
This lecture provides details of the types of information that should be included in the ISO 14971 risk management plan. It covers the definitions of the primary risk management activities such as risk analysis, risk estimation, risk evaluation and risk control as well as the sequence in which they should be conducted. The methods to perform these activities are discussed. Part 1 covers the identification of hazards and hazardous situations, risk analysis and risk estimation.
Part 2 covers risk evaluation, risk control measures and verification of risk control measure.
This quiz consists of 13 questions in the multiple choice format. These questions will test your knowledge of the ISO 14971 plan learnt in this section.
This lecture is an introduction to Failure Mode & Effects Analysis (FMEA). It provides a comparison between the FMEA and ISO 14971 risk management requirements.
This lecture dives deeper into how to use Annex C questions to identify hazards. Flowcharts are used to identify hazards and harms from a medical device example. At the end of this lecture, Workshop #4 - Annex C and Hazards Flowchart Practice provides a template to create Annex C flowcharts.
This lecture shows how hazard identification and risk estimation can be presented using the FMEA methodology. Ranking techniques for the probability of occurrence and the severity of harm are discussed here. The ISO14971 Workshop #5 - FMEA Worksheet is discussed throughout this lecture.
This lecture explains how to calculate, interpret and analyse risk rankings and the Risk Priority Number using the FMEA technique. It also looks closely at charts e.g. the [NxM] matrix, that assist in the comparison, presentation and documentation of risk levels. More charts can be downloaded from Workshop #6 - Risk Ranking Plots for practice purposes. Some examples of risk control measures are also discussed here.
This lecture explains how to deal with residual risks and the 3 possible effects of risk control measures. A technique for risk/benefit analysis is discussed. Calculations and formulae are provided. A Technical Report - Quantitative Risk/Benefit Analysis for Medical Devices can be downloaded for further reading on risk/benefit analysis.
The second part of this lecture further discusses about negligible risks and the concept of "as-low-as-reasonably-practicable" stated in the ISO 14971:2007 standard. The use of Fault-Tree and Event-Tree analysis to assess residual risks is demonstrated here. Download Workshop #7 - Fault-Tree & Event-Tree Analysis Practice to try creating your own Fault-Tree and Event-Tree flowcharts.
This quiz consists of 11 questions in the multiple choice format. These questions will test your knowledge of the FMEA technique learnt in this section.
This final lecture briefly discusses the importance of compiling all risk management processes, activities and results in a risk management file. Actions and outcomes must be duly recorded in a risk management report to facilitate decision-making and audits. Risk management is an integral part of the quality management system. This means risk management activities will be assessed during quality management system and product audits. Medical device risk management should continue beyond the design phase and throughout the production and post-production phases. The AAMI White Paper 2015 further illustrates additional requirements for post-market risk management. A short account can also downloaded on how Medtronic uses other tools to monitor risks and enhance product quality.
This quiz consists of 3 questions in the multiple choice format. These questions will test your knowledge of the post-production and post-market risk management obligations learnt in this section.
A former CEO of a successful CRO startup in Singapore from 2003 to 2008, Dr. Nealda Yusof’s experience in the medical technology sector spans 14 years. Specialising mainly in medical devices, she has been actively involved in the entire product lifecycle process ranging from research, regulatory, testing & validation, quality assurance, risk and crisis management, compliance and commercialisation. She advised multinational heavyweights in the healthcare sector such as GlaxoSmithKline and Edwards Lifesciences, and worked in close collaboration with NAMSA and Charles River. In 2012, she was appointed to an advisory role to the CEO in a renal care group and tasked to oversee teams in the United Kingdom, Germany, Egypt and Turkey. Her work involves setting guidelines for successful business operations, product development, R&D, subsidiary communications, project management, ERP system and organisational development strategies. Dr. Yusof uses her background in both science and law to provide a holistic combination of technical, regulatory and liability perspectives.
Dr. Nealda Yusof obtained her Doctor of Philosophy (Ph.D.) in Material Science from the National University of Singapore, and a Bachelor of Law (LLB) with Honours from the University of Birmingham in the United Kingdom.