Medical Devices: Risk Managment

Risk management is a process for identifying, evaluating and mitigating risk. For medical devices, this means product safety, including risks associated with harm to people and damage to property or the environment. Risk management has become an integral part of medical device design and development, production processes and evaluation of field experience. Risk management is applicable to all types of medical devices and evidence of its application is required by most regulatory bodies.

The management of risk for medical devices is described by the International Organization for Standardization (ISO) in ISO 14971:2007, Medical Devices—The application of risk management to medical devices, a product safety standard. This course examines the standard using specific examples. Topics addressed include management responsibilities, risk analysis and evaluation, risk controls and lifecycle risk management.

This course is not intended for implementing Enterprise Risk Management, but is oriented to product safety risk management, a completely separate process. It is important to remember throughout the course that the focus is on product safety for people (not just the patient), property and the environment.

The European version of the risk management standard was updated in 2009 and again in 2012 to refer to the Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) revision in 2007, as well as the In Vitro Medical Device Directive (IVDD). The requirements of EN ISO 14971:2012 are identical to ISO 14971:2007. The only difference is an Annex that refers to the new MDD and AIMDD. Throughout this course, when referring to ISO 14971:2007, it is understood that this includes the EN version of the standard as revised in 2012.

  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Registration Options

At A Glance

  • Target Audience: This course is intended for experienced professionals interested in the techniques of risk management as applied to product safety for medical devices. It is important to understand that the risk management standard requires any person who has responsibilities in a process that meets requirements under the standard be trained to meet those responsibilities. Among those with responsibilities under ISO 14971 are those members of executive management under Clause 3.
  • Learning Level: Basic
  • Total Length of Course: 4–8 Hours
  • RAC Credits: 4
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $455; List $630
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Learning Objectives

Upon completion of this course, participants should be able to:

  • Utilize risk management techniques to assess risk, including postmarket risk
  • Define risk management terms and concepts
  • Identify risk management guidance documents and standards
  • Explain how risk management is integrated into design control, production and post-production
  • Outline the application of risk management throughout the product lifecycle

Lesson Titles

  • Lesson 1: General Requirements for Risk Management
  • Lesson 2: Risk Assessment––Risk Analysis and Evaluation
  • Lesson 3: Risk Control
  • Lesson 4: Lifecycle Risk Management
  • Lesson 5: Risk Management Tools and Helps

Registration Options

This course is available for purchase as follows: