Applied ISO14971 Medical Device Risk Management

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 a pdf document showing the ISO 14971 Medical Device Risk Management Sequence.

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.  This lecture also contains Workshop #1 - Risk Management Communication Canvas.

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 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 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 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.