Iso 14971:2019 Risk Management For Medical Devices

Application 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