ISO 149712019 Risk Management for Medical Devices

Application Risk Management for medical devices
ISO 149712019 Risk Management for Medical Devices
File Size :
374.47 MB
Total length :
0h 56m



Syed Nadheem


Last update




ISO 149712019 Risk Management for Medical Devices

What you’ll learn

How ISO 14971:2019 Risk management
Risk management Policy
FMEA and it’s type
Hazard identification and types
Risk Benefit Analysis
Fault tree analysis
Risk Management Plan
Probability Estimation of Hazards
How to Use 5 × 5 Matrix
Residual Risks
Risk Acceptability Creteria
Risk Mitigation
Case studies of FMEA
Case Study of Risk Management
Documents of Risk Management File
Risk Control Measures

ISO 149712019 Risk Management for Medical Devices


Medical domain professionals/Engineers. No prior experience needed


Risk Management is one of the primary requirements for demonstrating compliance and conformance to Quality Management system requirements as per ISO 13485 Standard for Medical Device and In-vitro Diagnostic device manufacturers.While analyzing the reasons for the product failures often leads to inadequacy in understanding and implementing risk management in the organisation. This training is to create awareness of requirements and to have a better understandingThis course is designed to provide you with an understanding of Risk management Standard and the impact it has on the design, development, manufacturing and lifecycle of medical devices. It will also provide medical device manufacturers with knowledge of how to do the Risk management file. This course enables greater understanding of the impact that Risk Management standard has on the decision-making process when manufacturing medical devices. It helps medical device professionals understand how Risk management Standard can improve their business and risk management efforts.This course will help you to:Identify the key requirements of this standardInterpret and communicate the key requirements and expectations of ISO 20417 2021 to your organizationGain knowledge of how ISO 14971 2019 links to ISO 13485 and the MDR 2017 745Apply the fundamental risk management activities for medical devices within your organization.What you will learnUpon completion of this training, you will be able toDefine risk management terminologyExplain how risk management relates to the product lifecycleOutline the stages of the risk management processDefine the key deliverables of the risk management processApply risk management principles within your organization


Section 1: Course Agenda , Scope and Definitions

Lecture 1 Course Agenda

Lecture 2 Scope of ISO 14971:2019

Lecture 3 Important definitions in ISO 14971:2019

Section 2: 5X5 Matrix, Risk Management Policy and mitigation keys.

Lecture 4 5 X 5 Matrix

Lecture 5 Risk Management Policy

Lecture 6 Risk Mitigation Keys

Section 3: Risk Management Process and Risk management Plan

Lecture 7 Risk Management Process

Lecture 8 Risk Management Plan

Section 4: FMEA

Lecture 9 FMEA and it’s types

Lecture 10 RPN Number

Lecture 11 Case study FMEA with Examples

Section 5: Hazard Analysis

Lecture 12 Types of Hazards

Lecture 13 Hazard analysis | FTA


Section 6: Risk Benifit analysis and Risk management Report

Lecture 15 Risk Benifit Analysis

Lecture 16 Risk Estimation | Risk Management Report

Lecture 17 Periodic Review of Risk Management


Lecture 18 What’s New in ISO 14971 2019

Lecture 19 Overview of ISO 24971

Lecture 20 List of Risk Management Documents

Medical Device Professionals / Engineers,No Prior Experience Needed,Regulatory Specialist,Biomedical Engineer,PMS & PMCF Professionals,Design Engineers,Process Engineer,Production Engineer,Product Engineer,Application Engineer,Human Factors Engineer

Course Information:

Udemy | English | 0h 56m | 374.47 MB
Created by: Syed Nadheem

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