ISO 14971 and ISO 31000 – Medical Devices Risk Management for Product and Process

Description

MDRM

This course provides a comprehensive introduction to the key elements of Risk Management for Medical Devices, using the harmonised standard ISO 14971:2019, and aims to give delegates a practical foundation in the relationship between risk management, the regulatory requirements and their Quality System.

Objectives

By the end of this course, participants will be able to: 

• understand the key elements required for management of risk as specified in ISO 31000:2018
• understand the key elements required for management of medical device risk as specified in ISO 14971:2019
• gain an awareness of how to perform a Product Risk Assessment
• gain an awareness of how to perform a Process Risk Assessment
• gain an awareness of risk management requirements for Usability
• gain an awareness of the differences between the Directives and ISO 14971 (Annex Z)

Audience

This course comprises learning sessions and interactive workshops. Participants are expected to have basic knowledge of ISO 13485:2016 and risk management systems only before attending.