Online CourseOnline Course Medical Device Certificate ElectiveMedical Device Certificate Elective

Medical Devices: Risk Management [4.0 RAC]

4.0 RAC Credits Member: $465.00 Nonmember: $640.00
Medical Devices: Risk Management [4.0 RAC]
Risk management is a process for identifying, evaluating and mitigating risk. For medical devices, this refers to product safety and includes 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 a product safety standard by the International Organization for Standardization (ISO) in ISO 14971:2019, Medical devices— Application of risk management to medical devices.. Accordingly, this course examines this 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. Rather, this course is oriented to product safety risk management, which is a 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 14971:2012 are identical to ISO 14971:2007. The only difference is in the Informative Annexes ZA, ZB, and ZC, which refer to the new MDD and AIMDD as well as the IVDD. When referring to ISO 14971:2007,throughout this course, it is understood that this includes the EN version of the standard as revised in 2012.

The European Medical Device Regulations (MDR, 2017/765) and European In Vitro Device Regulation (IVDR, 2017/766) will replace the Medical Device Directives and the Active Implantable Medical Device Directives in May of 2021, as well as the In Vitro Device Regulation which will replace the In Vitro Device Directives in May of 2022. The most recently released version of ISO 14971, released in May 2019, reflects the requirements of these regulations. It is important to note that while ISO 14971:2019 is considered to be the state-of-the-art, it is not yet harmonized to either the MDD/AIMDD/IVDD or MDR/IVDR.

At a Glance
  • Target Audience: This course is intended for professionals of all experience levels 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 ISO 14971:2019 requires any person who is responsible for risk management tasks be competent in terms of education, training, skills, and experience.
  • Learning Level: Basic
  • Total Length of Course: 4 Hours
  • RAC Points: 4

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

Enrollment Period: 12 months
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