Single Course
Medical Devices
ISO 14971:2019 Risk Management for Med Device Introduction
Familiarize learners with an overview of ISO 14971:2019 Med Device. Application of risk management to medical devices and the differences between the 2012 and 2019 version.
1-Day
Virtual Class
English
Identifier: 129028884
Course Overview
What you'll learn
Upon completion of this course, learner 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
Who This Course Is For
The course is designed for:
- Medical professionals involved in the development and implementation of ISO 14971:2019 Risk Management for Medical Devices
About this course
The purpose of this course is to familiarize 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.
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