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 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

Who this course is for:
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

More Info