Understanding ISO 14971:2019 Requirements (Remote)

Course Description

This course is designed to introduce the ISO 14971:2019 – Risk Management for Medical Devices standard and provide participants with an understanding of the impact that risk management has on their decision-making process.  All elements of the standard will be covered, with an emphasis on the role of risk management in the medical device industry and the relationship between ISO 14971 and ISO 13485 Quality Management Systems.

Through a combination of presentation, group discussion, and moderated group activities, participants will gain a working knowledge of the ISO 14971:2019 requirements for medical device risk management, as well as practical experience applying the ISO 14971 risk management process to a medical device.

Who Should Take It

• Quality Managers or implementers within an organization seeking or maintaining registration to ISO 13485.
• Decision makers on management system strategy.
• Design Engineers, Process Engineers and Manufacturing Engineers.
• Internal Auditors
• Management Team

Learning Objectives

Through a combination of presentation, discussion and exercises, participants will:

• Review the role of Risk Management in the medical device industry.
• Understand the key concepts of Medical Device Risk Management and how they affect your organization.
• Learn the language and vocabulary used in the ISO 14971 standard.
• Understand the different steps in the Risk Management process, their interrelation, and how they are organized within ISO 14971.
• Thoroughly review the requirements of each section of ISO 14971 (see Course Content below).
• Practice understanding the relationships between hazards, foreseeable sequences of events, hazardous situations, and the harm that can occur.
• Carry out practical group activities to walk through the risk management process using a sample medical device.
• Understand the importance of management involvement with ISO 14971 implementation.

Course Content

• Introduction to ISO 14971
• ISO 14971 – Scope, Normative References, and Terms & Definitions
• ISO 14971 – Section 4 – General requirements for risk management system
• ISO 14971 – Sections 5 – 10 – Risk management process
  • Section 5 – Risk analysis
  • Section 6 – Risk evaluation
  • Section 7 – Risk control
  • Section 8 – Evaluation of overall residual risk
  • Section 9 – Risk management review
  • Section 10 – Production and post-production activities

Prerequisites

Participants should have experience with, or knowledge of, quality management systems for the medical device industry.  A basic awareness of medical devices, quality assurance, and ISO 13485 is recommended.