What does the ISO 14971 course cover?
ISO 14971 is covered here in 10 modules: Introduction to Risk Management: Overview of ISO 14971, Definition of risk management, Risk Management Principles: Risk review and update, Risk management process, Risk Identification and 7 more. The outline lists 29 specific topics, opening with definition of risk management and closing with certificate issuance.
How do you approach ISO 14971 step by step?
The work is sequenced in 10 stages. It starts with Introduction to Risk Management: Overview of ISO 14971, Definition of risk management, moves through Risk Management Principles: Risk review and update, Risk management process and Risk Identification, and ends at Certification and Final Assessment. Each stage carries its own topic list, so the sequence is followed rather than summarised.
What is in Module 1 of the ISO 14971 course?
Module 1 is Introduction to Risk Management: Overview of ISO 14971, Definition of risk management. It works through definition of risk management, importance of risk management in medical devices and overview of ISO 14971. It sets the vocabulary the remaining 9 modules build on.
How is the ISO 14971 course delivered?
The ISO 14971 course is fully self-paced with immediate online access after enrolment. Access does not expire and future updates are included at no cost. It can be taken on any device, and a certificate of completion is issued by The Art of Service when you finish.
How much does the ISO 14971 course cost?
The ISO 14971 course is $199 as a one time payment. There is no subscription, no per seat licence and no hidden fee. Enrolment carries a 30 day satisfied or refunded guarantee, so it can be assessed in full before you commit.
Closely related courses: Medical Device Reporting with Comprehensive Self, Medical Device Software Quality Management, IEC 60601 Standard Compliance for Medical Devices, Medical Device Reporting.
More answers: what you get with every course, refund policy, all help answers.
ISO 14971: A Complete Guide to Risk Management for Medical Devices - Practical Tools for Self-Assessment
Course Overview
This comprehensive course provides a detailed understanding of the principles and practices of risk management for medical devices, as outlined in the ISO 14971 standard. Participants will learn how to identify, analyze, and mitigate risks associated with medical devices, and how to implement a risk management system that meets regulatory requirements.Course Objectives
- Understand the principles and requirements of ISO 14971
- Learn how to identify and analyze risks associated with medical devices
- Understand how to mitigate and manage risks
- Implement a risk management system that meets regulatory requirements
- Apply practical tools for self-assessment
Course Outline
Module 1. Introduction to Risk Management: Overview of ISO 14971, Definition of risk management
- Definition of risk management
- Importance of risk management in medical devices
- Overview of ISO 14971
Module 2. Risk Management Principles: Risk review and update, Risk management process
- Risk management process
- Risk assessment
- Risk mitigation
- Risk review and update
Module 3: Risk Identification
- Hazard identification
- Hazard analysis
- Risk estimation
Module 4: Risk Analysis
- Qualitative risk analysis
- Quantitative risk analysis
- Semi-quantitative risk analysis
Module 5: Risk Mitigation
- Risk reduction
- Risk avoidance
- Risk transfer
Module 6. Risk Management System: Risk management policy, Risk management records
- Risk management policy
- Risk management procedure
- Risk management records
Module 7: Regulatory Requirements
- EU MDR
- EU IVDR
- US FDA
Module 8. Practical Tools for Self-Assessment: Risk assessment template, Risk management checklist
- Risk management checklist
- Risk assessment template
- Risk mitigation plan template
Module 9. Case Studies: Group discussions and exercises
- Real-world examples of risk management in medical devices
- Group discussions and exercises
Module 10: Certification and Final Assessment
- Final exam
- Certificate issuance
Course Features
- Interactive: Engaging video lessons, interactive quizzes, and group discussions
- Comprehensive: Covers all aspects of risk management for medical devices
- Personalized: Self-paced learning with flexible schedule
- Up-to-date: Latest regulatory requirements and industry best practices
- Practical: Real-world examples and case studies
- Expert instructors: Experienced professionals in risk management and medical devices
- Certification: Certificate issued upon completion
- Flexible learning: Accessible on desktop, tablet, or mobile device
- User-friendly: Easy-to-use online platform
- Community-driven: Discussion forum for networking and Q&A
- Actionable insights: Practical tools and templates for self-assessment
- Hands-on projects: Real-world exercises and group discussions
- Bite-sized lessons: Short, focused video lessons
- Lifetime access: Access to course materials forever
- Gamification: Engaging quizzes and challenges
- Progress tracking: Track your progress and stay motivated