ISO 14971: Risk Management for Medical Devices 2024

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Anil Sharma Kandel

1:50:08

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1. Introduction to ISO14971

1. Introduction.mp4

09:30

2. Applications and Benefits of ISO14971

1. Lifecycle of a Medical Device.mp4

08:37

2. Benefits of using ISO14971 in companies.mp4

06:56

3. Important Key Terms and Definitions

1. Key Terms and Definition used in ISO14971.mp4

05:54

4. Risk Management Process

1. Overview of Stages of Risk Management Process.mp4

04:17

2. Stage 1 Risk Analysis.mp4

08:13

3. Stage 2 & 3 Risk Evaluation and Risk Control.mp4

17:23

4. Stage 4a Risk Management Review.mp4

07:58

5. Stage 4b Post Production Activities.mp4

07:43

5. Create pFMEA, dFMEA and Risk Matrix from Scratch

1. Risk Matrix creation from scratch.mp4

06:47

2. pFMEA creation from Scratch.mp4

16:31

3. Create dFMEA and uFMEA from Scratch!.mp4

10:19

Description

Become an expert in ISO 14971 -Risk Measurement and Risk Management for medical device.

What You'll Learn?

Gain a deep understanding of ISO 14971 standard, including its purpose, scope, key terms, and specific requirements for a compliant RM system
Learn to apply the ISO 14971 risk management process to real medical devices. Master techniques for identifying hazard, analyzing risks, implementing controls.
Develop a comprehensive risk management plan. Learn to create a traceable risk management file to document the entire process
Master the pre-release risk management review. Collect and review information during production and post-prod, adapting and ensuring continuous improvement.

Who is this for?

Medical Device Professional wanting to learn about Risk Management Process used in Pharmaceuticals and Medical Device Companies

What You Need to Know?

No experience or prior curriculum required

More details

Description
Master medical device risk management with this comprehensive online course on ISO 14971:2019. This course provides a deep understanding of the standard, equipping you with the knowledge and skills to create a compliant and effective risk management system. You'll learn how to:

Understand ISO 14971: Grasp the standard's purpose, scope, key terminology, and requirements.
Apply Risk Management: Identify hazards, analyze risks, implement controls, and document the process effectively for real medical devices.
Create Essential Documents: Develop a comprehensive risk management plan and a traceable risk management file.
Review and Improve: Conduct a thorough risk management review and establish a system for continuous monitoring and improvement.
Gain the confidence: To conduct a thorough risk management review and establish a system for continuous monitoring and improvement.
Master medical device risk management with this comprehensive online course on ISO 14971:2019. This course provides a deep understanding of the standard, equipping you with the knowledge and skills to create a compliant and effective risk management system. You'll also master the creation of essential documents like a comprehensive risk management plan and a traceable risk management file.
Enroll today and gain the confidence to navigate the complexities of medical device risk management, ensuring the safety and effectiveness of your products.
Who this course is for:
Medical Device Professional wanting to learn about Risk Management Process used in Pharmaceuticals and Medical Device Companies

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Risk Management

Anil Sharma Kandel

Instructor's Courses

Anil Kandel lives and works in United States of America.Hi! Anil Sharma Kandel is an Industrial Engineer by education with vast experience in the Medical Device Industry. He has worked on Risk Management Activities for numerous commercial products and authored pilot risk management files for products in clinical trial phase and for commercial products. Throughout his career he has received several high level trainings in Risk Management Activities and CAPA activities and adding it to his years of experience in Risk management. He feels confident that he would be able to provide his students with the expert level knowledge and skills to be the top 5% in any enterprise.

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