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Mastering IEC 62304; A Step-by-Step Guide to Medical Device Software Development and Risk Management

Mastering IEC 62304; A Step-by-Step Guide to Medical Device Software Development and Risk Management

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Mastering IEC 62304: A Step-by-Step Guide to Medical Device Software Development and Risk Management



Course Overview

This comprehensive course provides a step-by-step guide to mastering IEC 62304, the international standard for medical device software development and risk management. Participants will receive a certificate upon completion, issued by The Art of Service.



Course Features

  • Interactive: Engage with expert instructors and peers through interactive discussions and hands-on projects.
  • Engaging: Enjoy a user-friendly and mobile-accessible learning platform with bite-sized lessons and gamification.
  • Comprehensive: Cover all aspects of IEC 62304, from software development to risk management.
  • Personalized: Receive personalized feedback and support from expert instructors.
  • Up-to-date: Stay current with the latest developments and updates in the field.
  • Practical: Apply theoretical knowledge to real-world applications and case studies.
  • High-quality content: Access high-quality course materials, including video lectures, readings, and quizzes.
  • Certification: Receive a certificate upon completion, issued by The Art of Service.
  • Flexible learning: Learn at your own pace, with lifetime access to course materials.
  • Community-driven: Join a community of professionals and stay connected with peers and instructors.
  • Actionable insights: Gain actionable insights and practical skills to apply in your career.


Course Outline

Module 1: Introduction to IEC 62304

  • Overview of IEC 62304 and its importance in medical device software development
  • Key concepts and terminology
  • History and evolution of the standard

Module 2: Software Development Life Cycle

  • Software development life cycle models
  • Requirements gathering and analysis
  • Design and implementation
  • Testing and validation
  • Maintenance and updates

Module 3: Risk Management

  • Risk management principles and concepts
  • Risk analysis and assessment
  • Risk mitigation and control
  • Risk monitoring and review

Module 4: Software Safety and Security

  • Software safety and security principles and concepts
  • Hazard analysis and risk assessment
  • Safety and security requirements
  • Design and implementation of safety and security features

Module 5: Verification and Validation

  • Verification and validation principles and concepts
  • Testing strategies and techniques
  • Test planning and execution
  • Test results analysis and reporting

Module 6: Documentation and Record-Keeping

  • Documentation and record-keeping principles and concepts
  • Software development documentation
  • Risk management documentation
  • Verification and validation documentation

Module 7: Audits and Inspections

  • Audit and inspection principles and concepts
  • Audit planning and execution
  • Inspection planning and execution
  • Audit and inspection reporting and follow-up

Module 8: Implementation and Maintenance

  • Implementation and maintenance principles and concepts
  • Software development and maintenance processes
  • Risk management and maintenance processes
  • Continuous improvement and updates


Certificate

Upon completion of the course, participants will receive a certificate issued by The Art of Service, demonstrating their mastery of IEC 62304 and their ability to apply its principles and concepts in medical device software development and risk management.

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