Risk Management and Risk Analysis for Medical Devices as per ISO 14971:2019

Course Description

The importance of risk management in medical technology will continue to grow in the future. Not only ISO 13485, but also the MDR and IVDR are based on sound risk management. A risk management system is and remains a central legal requirement for all medical device manufacturers worldwide. A systematic risk management according to ISO 14971 helps to fulfill these requirements.

After attending this seminar, you will know the basics of risk management for medical devices according to the applicable standards, based on the ISO 14971:2019 standard. In addition, you will learn about the innovations of the updated ISO/TR 24971:2020 guide. You will be able to correctly implement the risk management process in your company. You will know the objectives of the risk management plan and how to proceed with the risk analysis and how to properly document results.

Using concrete case studies, you will have ample opportunity on the second day to put the theoretical knowledge you have learned into practice step by step and to discuss any questions and difficulties that arise with the experts.

Who Should Attend

• QM Representatives
• Safety experts for medical devices
• Product managers, designers
• Personnel in charge of approval and design
• Personnel in regulatory affairs
• Consultants

Course Objectives

• You will get important know-how to be able to fulfil the obligation to introduce a risk management system for medical devices.
• You will be enabled to carry out standard-compliant risk analyses for medical devices.
• You will be able to implement the new ISO 14971:2019 in your company.

Course Contents

Day 1: Overview of the requirements for ISO 14971 and how to use them

• Applicable standards and normative references
• Terms and definitions
• General requirements for risk management system: process, responsibilities, competence of personnel, risk management plan and file
• Risk analysis
• Risk evaluation
• Risk control
• Evaluation of overall residual risk
• Risk management review and risk management file
• Production and post-production activities

• Impact of the risk analysis on the QM-system

Day 2: Practice-Oriented Workshop

• Practical implementation of the standards (ISO 14971)
• Implementation of risk analysis
• Developing of a risk management plan
• Different methods of risk analysis
• Carrying out a risk analysis

Requirements

No requirements are necessary

Methodology

This seminar addresses internationally valid standards and can also be held abroad. This seminar could be chosen as single training but is also part of a modular qualification: “I. and II. Party Process Auditor”.

After successful participation in the advanced modules, you could obtain the following recognized qualifications:

• International Regulatory Affairs Manager – TÜV (4611058)
• Medical Software Specialist – TÜV (foundation & advanced level)

Certificate

TÜV SÜD Academy Certificate of Attendance