Online Training Course - An Introduction to Risk Management of Medical Devices - ISO 14971:2019+A11:2021

Introduction

In this training course you will learn about the Medical Device Risk Management standard ISO 13485:2016+A11:2021.

This standard identifies what is required to create and manage a Risk Management System used for the risk management of medical devices throughout their product life cycle. 

We will go through each clause of the ISO 14971 standard to give you a fully comprehensive overview and understanding of the standard and how it applies to organisations that design, develop, manufacture or distribute medical devices.

This immersive training course will benefit quality assurance professionals starting out with ISO 14971, top management looking to get an overview of ISO 14971, people with a general interest in ISO 14971 and personnel who are involved in contributing to their companies design and development of medical devices.

Taking part on this training course will give you skills and education in all areas relating to an ISO 14971 Risk Management System. The course is modular based and fully online, allowing for distance learning. Participants can go at their own pace giving the freedom to learn at times suitable for you. Unlike other similar courses there is no live lessons or requirement to attend a venue, this gives full flexibility to the participant to learn during hours that suit them rather than the learning provider. 

The training course contains explainer videos and at the end of each module is a test quiz to embed the learning. At the end of the training course a certificate of completion will be provided. This can go with your training records to show continued learning and competency in understanding knowledge of an ISO 14971 Risk Management approach to Medical Devices.  

Course Content:

• Course Introduction
• Module 1 - The Scope and Purpose of ISO 14971
• Lesson 1 - The Purpose and the Scope of ISO 14971

• Module 2 - The Clauses of ISO 14971
• Lesson 1 - The Clauses of ISO 14971

• Module 3 - The General Requirements of the Standard
• Lesson 1 - The Risk Management Process
• Lesson 2 - Management Responsibilities
• Lesson 3 - Competence of Personnel
• Lesson 4 - Risk Management Plan
• Lesson 5 - Risk Management File
• End of Module Quiz

• Module 4 - Performing Risk Analysis 
• Lesson 1 - The Risk Analysis Process
• Lesson 2 - Intended use and reasonably foreseeable misuse 
• Lesson 3 - Identification of Characteristics Related to Safety
• Lesson 4 - Identification of Hazards and Hazardous Situations 
• Lesson 5 - Risk Estimation
• End of Module Quiz

• Module 5 - Performing Risk Evaluation
• Lesson 1 - Risk Evaluation
• End of Module Quiz

• Module 6 - Performing Risk Control
• Lesson 1 - Risk Control Option Analysis
• Lesson 2 - Implementation of Risk Control Measures
• Lesson 3 - Residual Risk Evaluation
• Lesson 4 - Benefit-Risk Analysis 
• Lesson 5 - Risks Arising from Risk Control Measures
• Lesson 6 - Completeness of Risk Control
• End of Module Quiz

• Module 7 - Evaluating Overall Residual Risks
• Lesson 1 - Evaluating Overall Residual Risks 

• Module 8 - Performing Risk Management Review
• Lesson 1 - Risk Management Review 

• Module 9 - Performing Production and Post-Production Risk Management
• Lesson 1 - General Requirements
• Lesson 2 - Information Collection
• Lesson 3 - Information Review
• Lesson 4 - Actions
• End of Module Quiz

Course Length:

 This course will take approximately 1 hours to complete. 

Course Audience:

• Quality Engineers
• Quality Assurance Managers
• Quality Assurance Officers
• Clinical Team Members 
• CEO, CFO, COO, CTO, President, Managing Directors
• Medical Device Project Managers
• Medical Device Design & Development Team
• Medical Device Software Engineers 
• Medical Device Purchasing Team 
• People with general interest 

Certificate:

Certificate of completion with name of person, date of completion and title of course, signed and dated by our team.