ISO 14971:2019 Risk Management for Medical Devices

ISO 14971:2019 Risk Management for Medical Devices, available at $49.99, has an average rating of 4.25, with 20 lectures, 7 quizzes, based on 90 reviews, and has 209 subscribers.

You will learn about 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 This course is ideal for individuals who are Medical Device Professionals / Engineers or No Prior Experience Needed or Regulatory Specialist or Biomedical Engineer or PMS & PMCF Professionals or Design Engineers or Process Engineer or Production Engineer or Product Engineer or Application Engineer or Human Factors Engineer It is particularly useful for Medical Device Professionals / Engineers or No Prior Experience Needed or Regulatory Specialist or Biomedical Engineer or PMS & PMCF Professionals or Design Engineers or Process Engineer or Production Engineer or Product Engineer or Application Engineer or Human Factors Engineer.

Enroll now: ISO 14971:2019 Risk Management for Medical Devices

Summary

Title: ISO 14971:2019 Risk Management for Medical Devices

Price: $49.99

Average Rating: 4.25

Number of Lectures: 20

Number of Quizzes: 7

Number of Published Lectures: 20

Number of Published Quizzes: 7

Number of Curriculum Items: 27

Number of Published Curriculum Objects: 27

Original Price: $19.99

Quality Status: approved

Status: Live

What You Will 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

Who Should Attend

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

Target Audiences

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

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 understanding

This 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 standard
Interpret and communicate the key requirements and expectations of ISO 20417 2021 to your organization
Gain knowledge of how ISO 14971 2019 links to ISO 13485 and the MDR 2017 745
Apply the fundamental risk management activities for medical devices within your organization.

What you will learn

Upon completion of this training, you will be able to

Define risk management terminology
Explain how risk management relates to the product lifecycle
Outline the stages of the risk management process
Define the key deliverables of the risk management process
Apply risk management principles within your organization

Course Curriculum

Chapter 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

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

Lecture 1: 5 X 5 Matrix

Lecture 2: Risk Management Policy

Lecture 3: Risk Mitigation Keys

Chapter 3: Risk Management Process and Risk management Plan

Lecture 1: Risk Management Process

Lecture 2: Risk Management Plan

Chapter 4: FMEA

Lecture 1: FMEA and it's types

Lecture 2: RPN Number

Lecture 3: Case study FMEA with Examples

Chapter 5: Hazard Analysis

Lecture 1: Types of Hazards

Lecture 2: Hazard analysis | FTA

Lecture 3: ISO 24971 GUIDANCE FOR HAZARD IDENTIFICATION

Chapter 6: Risk Benifit analysis and Risk management Report

Lecture 1: Risk Benifit Analysis

Lecture 2: Risk Estimation | Risk Management Report

Lecture 3: Periodic Review of Risk Management

Chapter 7: ISO 24971 | LIST OF RISK MANAGEMENT DOCUMENTS

Lecture 1: What's New in ISO 14971 2019

Lecture 2: Overview of ISO 24971

Lecture 3: List of Risk Management Documents

Instructors

Syed Nadheem
MEDICAL DEVICE EXPERT | REGULATORY | MECHANICAL DESIGN

Rating Distribution

1 stars: 4 votes
2 stars: 5 votes
3 stars: 32 votes
4 stars: 29 votes
5 stars: 20 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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