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Mastering ISO 14971; A Step-by-Step Guide to Conducting Effective Risk Management and Ensuring Medical Device Safety

Mastering ISO 14971; A Step-by-Step Guide to Conducting Effective Risk Management and Ensuring Medical Device Safety

$199.00
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What does the ISO 14971 course cover?

ISO 14971 is covered here in 10 modules: Introduction to ISO 14971: Overview of ISO 14971, Key concepts and terminology, Risk Management Principles: Risk evaluation and control, Risk Management Process: Risk review and update, Risk control and mitigation and 7 more.

How do you approach ISO 14971 step by step?

The work is sequenced in 10 stages. It starts with Introduction to ISO 14971: Overview of ISO 14971, Key concepts and terminology, moves through Risk Management Principles: Risk evaluation and control and Risk Management Process: Risk review and update, Risk control and mitigation, and ends at Case Studies and Best Practices: Lessons learned and common pitfalls.

What is in Module 1 of the ISO 14971 course?

Module 1 is Introduction to ISO 14971: Overview of ISO 14971, Key concepts and terminology. It works through overview of ISO 14971, history and development of the standard, key concepts and terminology and 1 more. 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 Classification and Medical Device, Medical Device Reporting and Medical Device Regulation, Medical Device Reporting Toolkit, Medical Device Reporting System Toolkit.

More answers: what you get with every course, refund policy, all help answers.

Mastering ISO 14971: A Step-by-Step Guide to Conducting Effective Risk Management and Ensuring Medical Device Safety

Mastering ISO 14971: A Step-by-Step Guide to Conducting Effective Risk Management and Ensuring Medical Device Safety



Course Overview

This comprehensive course provides a step-by-step guide to conducting effective risk management and ensuring medical device safety in accordance with ISO 14971. Participants will receive a certificate upon completion issued by The Art of Service.



Course Features

  • Interactive: Engage with interactive lessons and activities to enhance your learning experience.
  • Engaging: Enjoy a user-friendly interface and bite-sized lessons to keep you engaged.
  • Comprehensive: Cover all aspects of ISO 14971 and risk management for medical devices.
  • Personalized: Get personalized feedback and support from expert instructors.
  • Up-to-date: Stay up-to-date with the latest developments and best practices in risk management.
  • Practical: Apply your knowledge to real-world scenarios and case studies.
  • Real-world applications: Learn from real-world examples and case studies.
  • High-quality content: Access high-quality content developed by expert instructors.
  • Expert instructors: Learn from experienced instructors with expertise in risk management and medical devices.
  • Certification: Receive a certificate upon completion issued by The Art of Service.
  • Flexible learning: Learn at your own pace and on your own schedule.
  • User-friendly: Enjoy a user-friendly interface and easy navigation.
  • Mobile-accessible: Access the course on your mobile device or tablet.
  • Community-driven: Join a community of professionals and connect with peers.
  • Actionable insights: Gain actionable insights and practical tips to apply to your work.
  • Hands-on projects: Complete hands-on projects to apply your knowledge and skills.
  • Bite-sized lessons: Learn in bite-sized chunks to fit your busy schedule.
  • Lifetime access: Enjoy lifetime access to the course materials and updates.
  • Gamification: Engage with gamification elements to make learning fun and engaging.
  • Progress tracking: Track your progress and stay motivated.


Course Outline

Module 1. Introduction to ISO 14971: Overview of ISO 14971, Key concepts and terminology

  • Overview of ISO 14971
  • History and development of the standard
  • Key concepts and terminology
  • Relationship with other standards and regulations

Module 2. Risk Management Principles: Risk evaluation and control

  • Definition of risk and risk management
  • Risk management principles and framework
  • Identification and analysis of hazards
  • Risk evaluation and control

Module 3. Risk Management Process: Risk review and update, Risk control and mitigation

  • Risk management process overview
  • Risk identification and analysis
  • Risk evaluation and prioritization
  • Risk control and mitigation
  • Risk review and update

Module 4. Hazard Identification and Analysis: Fault tree analysis (FTA)

  • Hazard identification techniques
  • Hazard analysis and risk estimation
  • Failure mode and effects analysis (FMEA)
  • Fault tree analysis (FTA)

Module 5. Risk Evaluation and Control: Risk evaluation criteria and methods

  • Risk evaluation criteria and methods
  • Risk control and mitigation strategies
  • Design and implementation of risk controls
  • Verification and validation of risk controls

Module 6. Risk Management for Medical Devices: Medical device risk management overview

  • Medical device risk management overview
  • Risk management for medical device design
  • Risk management for medical device manufacturing
  • Risk management for medical device post-market surveillance

Module 7. ISO 14971 Implementation and Certification: ISO 14971 implementation process

  • ISO 14971 implementation process
  • Gap analysis and readiness assessment
  • Implementation planning and project management
  • Certification audit and maintenance

Module 8. Auditing and Compliance: Audit execution and reporting, Audit planning and preparation

  • Auditing principles and techniques
  • Compliance with ISO 14971 and regulatory requirements
  • Audit planning and preparation
  • Audit execution and reporting

Module 9. Risk Management Tools and Techniques: Risk management software and tools

  • Risk management software and tools
  • Failure mode and effects analysis (FMEA) software
  • Fault tree analysis (FTA) software
  • Sensitivity analysis and simulation

Module 10. Case Studies and Best Practices: Lessons learned and common pitfalls

  • Real-world case studies and examples
  • Best practices for risk management and ISO 14971 implementation
  • Lessons learned and common pitfalls
  • Future trends and developments in risk management


Certificate of Completion

Upon completing the course, participants will receive a Certificate of Completion issued by The Art of Service.

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