Skip to main content
ISO 14971 Risk Management for Medical Devices Implementation and Auditing

ISO 14971 Risk Management for Medical Devices Implementation and Auditing

$199.00
When you get access:
Course access is prepared after purchase and delivered via email
How you learn:
Self-paced • Lifetime updates
Your guarantee:
30-day money-back guarantee — no questions asked
Who trusts this:
Trusted by professionals in 160+ countries
Toolkit Included:
Includes a practical, ready-to-use toolkit with implementation templates, worksheets, checklists, and decision-support materials so you can apply what you learn immediately - no additional setup required.
Adding to cart… The item has been added

ISO 14971 Risk Management for Medical Devices Implementation and Auditing Course Curriculum

This comprehensive course is designed to provide participants with in-depth knowledge and practical skills in implementing and auditing risk management for medical devices according to ISO 14971. Upon completion, participants will receive a certificate issued by The Art of Service.



Course Overview

This interactive and engaging course is structured into 8 modules, covering over 80 topics. The curriculum is designed to be comprehensive, personalized, and up-to-date, with a focus on real-world applications and practical insights.



Course Outline

Module 1: Introduction to ISO 14971 and Risk Management

  • Overview of ISO 14971 and its importance in medical device regulation
  • Understanding risk management principles and concepts
  • Risk management process and its application to medical devices
  • Key terms and definitions related to risk management

Module 2: Risk Management Process

  • Risk analysis: identifying hazards and estimating risks
  • Risk evaluation: determining the acceptability of risks
  • Risk control: implementing measures to mitigate or eliminate risks
  • Monitoring and review of risk management activities

Module 3: Risk Management for Medical Devices

  • Application of risk management to medical device design and development
  • Risk management for medical device production and manufacturing
  • Risk management for medical device use and maintenance
  • Case studies: risk management for various medical devices

Module 4: ISO 14971 Requirements and Implementation

  • Understanding the requirements of ISO 14971
  • Developing a risk management plan
  • Implementing risk management processes and procedures
  • Documentation and record-keeping for risk management

Module 5: Auditing Risk Management

  • Principles of auditing risk management
  • Auditing risk management processes and procedures
  • Auditing risk management documentation and records
  • Case studies: auditing risk management for medical devices

Module 6: Risk Management Tools and Techniques

  • Failure Mode and Effects Analysis (FMEA)
  • Fault Tree Analysis (FTA)
  • Hazard and Operability (HAZOP) study
  • Other risk management tools and techniques

Module 7: Case Studies and Group Exercises

  • Case studies: risk management for various medical devices
  • Group exercises: applying risk management principles and concepts
  • Group discussions: sharing experiences and best practices

Module 8: Course Wrap-up and Certification

  • Summary of key takeaways
  • Certification: participants receive a certificate upon completion


Course Features

This course is designed to be:

  • Interactive: engaging and participatory, with group exercises and discussions
  • Comprehensive: covering over 80 topics related to ISO 14971 and risk management
  • Personalized: tailored to meet the needs of individual participants
  • Up-to-date: reflecting the latest developments and best practices in risk management
  • Practical: focusing on real-world applications and case studies
  • High-quality content: developed by expert instructors with extensive experience
  • Flexible learning: accessible online, with lifetime access to course materials
  • User-friendly: easy to navigate and use, with mobile accessibility
  • Community-driven: with opportunities for discussion and networking
  • Actionable insights: providing participants with practical knowledge and skills
  • Hands-on projects: applying risk management principles and concepts to real-world scenarios
  • Bite-sized lessons: breaking down complex topics into manageable chunks
  • Gamification: incorporating game design elements to enhance engagement and motivation
  • Progress tracking: allowing participants to track their progress and achievements
Upon completion, participants will receive a certificate issued by The Art of Service, demonstrating their expertise in ISO 14971 risk management for medical devices.

,
!