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
Requirements
Medical domain professionals/Engineers. No prior experience needed
Description
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
Overview
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
Lecture 14 ISO 24971 GUIDANCE FOR HAZARD IDENTIFICATION
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
Section 7: ISO 24971 | LIST OF RISK MANAGEMENT DOCUMENTS
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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