Virtual Class (1 Class)
82084737English
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.
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 Course requirements:
To ensure your access to the virtual course and to gain the most out of this training we request all learners have:
- Reliable internet access (High speed)
- Computer with microphone and camera capabilities
Virtual Class (1 Class)
82084737English