ISO 14971:2019 Practical Application of Risk Management to Medical Devices Course

Virtual Learning

July 7 – 8, 2021

Course Overview

This training course is 16 hours. ISO 14971 states that manufacturers shall establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is considered an integral part of a manufacturer’s QMS. This course presents the key foundations of the risk management process as defined in ISO 14971 and provides expert tips on how to navigate the process.

This virtual instructor led two-day course is highly interactive and includes practical instruction, case study exercises, and competency assessment. Provides an understanding of the risk management standard (ISO 14971:2019). This course includes a two-hour ISO 14971 overview module that must be completed prior to the start of the live instruction. At the end of the course, you will understand how to:

· Evaluate the fundamental requirements of the medical device
regulation relating to risk management

· Apply the ISO 14971 step-wise approach of risk identification,
assessment, control and evaluation

· Know how to implement risk management within the product
development, product manufacturing and post-market phases of
a product lifecycle Establish risk acceptability criteria

· Use risk management tools and activities for defining product
characteristics to prepare risk management summaries for
regulatory submission

· Understand the tools, techniques, information and records
required to develop a successful risk management program and
use as a basis for U.S. regulatory reviews

This course includes a two-hour ISO 14971 overview eLearning module that must be completed prior to the start of the live instruction.

Learning Objectives

· Identify the structure and key concepts of ISO 14971 including
production and post-production risk management requirements

· Understand the process of CAPA activities and postmarket
surveillance

· Understand each step of the risk management process, including
risk management planning, risk analysis, risk evaluation, risk
management review and reporting, etc.

· Create an effective risk management plan

· Identify regulatory requirements for risk management

o European Regulation EU 2017/745 (EU MDR)

o European Regulation EU 2017/746 (EU IVDR)

o 21 CFR 820.30(g)

· Identify requirements of key International Standards relative to risk management

1. ISO 14971:2019

2. ISO 13485:2016

· Recognize risk management definitions and principles

· Identify how risk management affects quality management system practices

· Recognize one method for the practical application of risk management principles

Who Should Attend

This course is vital for any medical device professional looking to expand their knowledge on comprehensive Risk Management processes and explain their interactions with the design and development activities of an organization.