• views: 97
• date: 22 August 2024
• posted by: voska89

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.
Requirements
No experience or prior curriculum required
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
Homepage

https://www.udemy.com/course/iso14971/

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