ISO 14971:2019 Application of risk management to medical devices

Agenda

Module 1      Risk Management Introduction

Module 2         Risk Management Terms and Definitions

Module 3         ISO 14971:2019 Overall structure and content 

Module 4         ISO 14971:2019 General  Requirements for Risk Management 

Module 5     ISO 14971:2019 Risk Analysis

Module 6         Risk Evaluation

Module 7         Risk Control

Module 8         Evaluation of overall residual risk

Module 9      Risk management review

Module 10       Production and Post Production  Information

Module 11      ISO TR 24971 and its relationship to ISO 14971: 2019

Module 12      Cognitive Bias

Module 13      What Level of Risk do we accept 

Module 14       Risk Benefit Analysis 

Module 15      Risk Management Techniques

Learning Objectives

This 1-day practical Risk Analysis training course for medical devices is based on ISO 14971:2019. It examines all steps of the risk management process and the application of this to medical devices. Risk assessment involves risk analysis and risk evaluation, followed by risk control and finally post-production information gathering.

Risk can be measured by medical device practitioners and is required by FDA’s Quality System Regulation (QSR) and the Annex I Essential Requirements of MDR 2017/745- GENERAL SAFETY AND PERFORMANCE REQUIREMENTS. 

The EU requires a risk analysis for all medical devices to be completed. This live documentation should reside in our technical files, including those already on the market.