INTRODUCTION

ISO 14971 is an ISO standard for the application of risk management to medical devices. ISO 14971:2019 was released mid-December, and the EN version was released on December 18, 2019 to replace the ISO 14971:2007 and EN ISO 14971:2012 respectively. The latest version EN ISO 14971:2019 +A11:2021 is released in 2021.

Main highlighted of the updates is as follows:

• The key concepts and core approach to risk management was maintained
• Clarification was added around the following:
• Production and post-production information
• Clinical benefits and risk-benefit analysis
• Update the guidance in the annexes
• Revise ISO/TR 24971- The Technical Report that provides guidance on the application of ISO 14971

• Informative Annexes would primarily reside in ISO TR 24971 because it is easier to update a Technical Report than it is a standard. A new Clause was added: Clause 2 on Normative References. As a result, all Clauses past Clause 1 are incremented by 1.
• While the Technical Report complements the standard, it is important to note that the information in ISO TR 24971:2019 serves only as a guidance, and not requirements. As well, the first 3 annexes in ISO 14971:2019 act as guidance, and not requirements. The ISO/TR 24971:20XX has not been released yet.

COURSE OBJECTIVE

This training aims to provide participants with a clear understanding and insight into the new EN ISO 14971:2019+A11:2021 requirements. The training takes a look at what the major changes in 2019 updates/revision and also covers some of the commonly used risk management tools such as FMEA, FTA etc.

COURSE OUTLINE

• EN ISO 14971:2019+A11:2021 Requirements
  • Clause 1 Scope
  • Clause 2 Normative Reference
  • Clause 3 Terms and Definitions
  • Clause 4 General Requirements for Risk Management System
  • Clause 4.1 Risk Mgt Process
  • Clause 4.2 Management Responsibilities
  • Clause 4.3 Competence of Personnel
  • Clause 4.4 Risk Management Plan
  • Clause 4.5 Risk Management File
  • Clause 5 Risk Analysis
  • Clause 6 Risk Evaluation
  • Clause 7 Risk Control
  • Clause 8 Evaluation of Overall Residue Risk
  • Clause 9 Risk Management Review
  • Clause 10 Production and Post-Production Activities
• Review on EN ISO 14971:2012 Annex Z on Potential New Annex in EN ISO 14971:20XX
• ALARP Concept
• Summary
• Extra Information

TARGET AUDIENCE

Professionals from quality assurance, regulatory affairs, research and development, process improvement, manufacturing and others who involve and wish to understand how to apply and develop proper risk management documentation for product and process of medical device industry.

PRE-REQUISITES

Basic understanding of the ISO 13485:2016 and use of risk management tools such as FMEA is an added advantage. Previous knowledge of ISO 14971:2007 or EN ISO 14971:2012 is not required.