Because Quality Starts with Education

Dive into the essential principles of IEC 62304, the international standard for software lifecycle processes in medical devices. This comprehensive course is designed for developers, quality managers, and regulatory professionals, offering practical insights to ensure compliance, manage risk, and incorporate state-of-the-art cybersecurity measures. Learn how to apply IEC 62304 to software with integrated AI/ML technologies and protect against cybersecurity threats, including data breaches and unauthorized system access.

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Quality Management System in the cloud

The workshop is built around confinis electronic Quality Management System openQMS™  powered by the Atlassian cloud ecosystem. openQMS™ facilitates ISO 13485 compliance for companies and certification for medical devices by managing SOPs, templates, and automated records via Confluence and Jira. Specific SOPs and templates following IEC 62304 are integrated to support Software as Medical Device development and certification. 

Find out more about the advantages of an electronic QMS in the cloud here.

Highlights

  • Comprehensive IEC 62304 Coverage

    Master the essentials of software lifecycle management for medical devices, from planning to verification, aligned with IEC 62304 standards.

  • Cybersecurity Best Practices

    Learn how to implement robust cybersecurity measures to protect medical devices from threats, ensuring compliance with FDA and MDR requirements.

  • AI Integration Strategies

    Discover how to integrate AI/ML technologies into medical device software while navigating regulatory challenges and maintaining compliance.

Learn at your own pace

Once subscribed you will have access at the whole course content. Follow lessons in the order you prefer. Take tests as many time as you need. Complete all lessons and quiz to get your IEC 62304 confinis course certificate.

  • 3 hours of lessons

  • 10+ quiz at the end of the lessons

  • Follow lessons as many times as you need

Course curriculum

    1. Introduction to the course

      FREE PREVIEW

    1. Introduction

      FREE PREVIEW

    2. Introduction to IEC 62304

    3. Quiz 1

    4. Software Safety Classification

    5. Quiz 2

    6. Software Development Process - Intro

    7. Quiz 3

    8. Software Development Planning

    9. Quiz 4

    10. Software Requirements Analysis

    11. Quiz 5

    12. Software Architectural Design

    13. Quiz 6

    14. Detailed Design, Implementation and Verification

    15. Quiz 7

    16. Software Integration, Testing and Release

    17. Quiz 8

    18. Software Verification

    19. Quiz 9

    20. Software Maintenance

    21. Quiz 10

    22. Software Problem Resolution

    23. Quiz 11

    24. Configuration Management and Traceability

    25. Quiz 12

    26. Common Questions

    27. Quiz 13

    28. Cybersecurity

    29. Quiz 14

    30. AI/ML

    31. Quiz 15

    1. Introduction

    2. Quiz 1

    3. Regulatory compliance

    4. Quiz 2

    5. Cybersecurity for Legacy Medical Devices

    6. Quiz 3

    7. Cybersecurity documentation

    8. Quiz 4

    9. Practical steps for manufacturers

    10. Quiz 5

    1. Introduction to AI and Medical Devices

    2. Current Regulatory Landscape

    3. The Future of AI and Medical Devices

    4. Implications for Manufacturers

    5. AI Quiz

About this course

  • CHF149.00
  • 47 lessons
  • quiz at the end of lessons
  • certificate of completion
  • full access for 60 days

FAQ

  • When am I supposed to follow the course?

    You have full access to the course content 24/7 during 60 days after purchase and you can follow the lessons in the order you prefer.

  • What's the total duration of the course?

    The course is composed by 47 lessons of 5 to 15 minutes each. If you spend 1-2 hours per day on the course expect to complete it in 4 days roughly.

  • How do I check my progress?

    Most lessons are followed by a quiz to test your knowledge. You can take the quiz as many time as you want until you feel confident to continue.

  • Will I get a certificate of completion?

    Yes! At the end of the course after having followed all lessons and taken al quizzes, you will get you confinis certificate of completion that you can share and use as you like on social media and other channels.