Virtual Class
82084737
Description
The purpose of this course is to familiarise learners with an overview of ISO 14971:2019 Medical Devices Application of risk management to medical devices and the differences between the 2012 and 2019 version.Course Content
- Introduction to ISO 14971:2019
- Planning for risk management
- Risk analysis and evaluation
- Risk control
- Usability and risk management
- Report and post-production information
On completion of this course Learners will be issued with a "Certificate of Attendance"
Objectives
Upon completion of this course, learners will be able to:- Identify the key elements required for management of medical device risk as specified in ISO 14971:2019
- Identify the key changes in the third edition of ISO 14971:2019
- Explain at what stage in the process each of their Medical Devices is within the lifecycle of risk
- Gain an awareness of how to perform a Product Risk Assessment
- Explain the risk management requirements for Usability
- Identify the differences between the Directives and EN ISO 14971:2012 (Annex Z), and why they remain applicable
Audience
This course is designed for:- Medical professionals involved in the development and implementation of ISO 14971:2019 Risk Management for Medical Devices
Prior Knowledge
It will benefit learners if they have a knowledge of the following principles and concepts:
- Experience and knowledge of quality management systems for medical devices and medical device development
- Basic awareness of quality assurance and ISO 13485:2016
Virtual Class
82084737