Certification Course: Medical Device Risk Management 2024

Certification Course: Medical Device Risk Management 2024, available at $44.99, with 13 lectures.

You will learn about 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. This course is ideal for individuals who are Medical Device Professional wanting to learn about Risk Management Process used in Pharmaceuticals and Medical Device Companies It is particularly useful for Medical Device Professional wanting to learn about Risk Management Process used in Pharmaceuticals and Medical Device Companies.

Enroll now: Certification Course: Medical Device Risk Management 2024

Summary

Title: Certification Course: Medical Device Risk Management 2024

Price: $44.99

Number of Lectures: 13

Number of Published Lectures: 13

Number of Curriculum Items: 13

Number of Published Curriculum Objects: 13

Original Price: $94.99

Quality Status: approved

Status: Live

What You Will 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 Should Attend

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

Target Audiences

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

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.

Enroll today and gain the confidence to navigate the complexities of medical device risk management, ensuring the safety and effectiveness of your products.

Course Curriculum

Chapter 1: Introduction to ISO14971

Lecture 1: Introduction

Chapter 2: Applications and Benefits of ISO14971

Lecture 1: Types of Medical Devices Covered by ISO 14971

Lecture 2: Lifecycle of a Medical Device

Lecture 3: Benefits of using ISO14971 in companies

Chapter 3: Important Key Terms and Definitions

Lecture 1: Key Terms and Definition used in ISO14971

Chapter 4: Risk Management Process

Lecture 1: Overview of Stages of Risk Management Process

Lecture 2: Stage 1: Risk Analysis

Lecture 3: Stage 2 & 3 : Risk Evaluation and Risk Control

Lecture 4: Stage 4a: Risk Management Review

Lecture 5: Stage 4b: Post Production Activities

Chapter 5: Create pFMEA, dFMEA and Risk Matrix from Scratch

Lecture 1: Risk Matrix creation from scratch

Lecture 2: pFMEA creation from Scratch

Lecture 3: Create dFMEA and uFMEA from Scratch!

Instructors

Anil Sharma Kandel
Industrial and Manufacturing Engineer

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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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