ISO 14971:2019 Risk Management for Medical Devices
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ISO 14971:2019 Risk Management for Medical Devices at UDEMY Overview
Duration | 1 hour |
Total fee | ₹399 |
Mode of learning | Online |
Credential | Certificate |
ISO 14971:2019 Risk Management for Medical Devices at UDEMY Highlights
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ISO 14971:2019 Risk Management for Medical Devices at UDEMY Course details
- 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
- 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 organization. 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 standardInterpret 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 745Apply the fundamental risk management activities for medical devices within your organization. What you will LearnUpon 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
ISO 14971:2019 Risk Management for Medical Devices at UDEMY Curriculum
Course Agenda , Scope and Definitions
Course Agenda
Scope of ISO 14971:2019
Important definitions in ISO 14971:2019
Quiz 1
5X5 Matrix, Risk Management Policy and mitigation keys.
5 X 5 Matrix
Risk Management Policy
Risk Mitigation Keys
Quiz 2
Risk Management Process and Risk management Plan
Risk Management Process
Risk Management Plan
Quiz 3
FMEA
FMEA and it's types
RPN Number
Case study FMEA with Examples
Quiz 4
Hazard Analysis
Types of Hazards
Hazard analysis
FTA
ISO 24971 GUIDANCE FOR HAZARD IDENTIFICATION
Quiz 5
Risk Benifit analysis and Risk management Report
Risk Benifit Analysis
Risk Estimation
Risk Management Report
Periodic Review of Risk Management
Quiz 6
ISO 24971
LIST OF RISK MANAGEMENT DOCUMENTS
What's New in ISO 14971 2019
Overview of ISO 24971
List of Risk Management Documents
Quiz 7
ISO 14971:2019 Risk Management for Medical Devices at UDEMY Faculty details
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