Special offer: 25% off!

Join us for our brand-new webinar on ISO 13485 compliance for medical devices, and get a comprehensive understanding of the latest standards and best practices. To celebrate the launch, we're offering an exclusive 25% discount for a limited time! Use code: confinis25 at checkout to secure your spot and save! Don’t miss out on this opportunity to enhance your compliance knowledge at a great price. Register now and take the first step towards mastering ISO 13485!

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Electronic document control

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. 

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

Highlights

  • Strategic Insights

    Get access to expert knowledge on QMS essentials and global market strategies. Learn how to effectively integrate a Quality Management System into your business for enhanced compliance and market access.

  • Efficiency Through eQMS

    Discover the latest in electronic Quality Management Systems (eQMS) to streamline your operations. Our sessions cover key aspects of design, development, and implementation, ensuring efficiency and regulatory compliance.

  • Future-Ready Focus

    Stay ahead with our deep dives into software development, cybersecurity, and AI applications in medical devices. Equip your startup with cutting-edge skills and knowledge for operational excellence and innovation.

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 ISO 13485 confinis course certificate.

  • 10 hours of lessons

  • 50+ quiz at the end of the lessons

  • Follow lessons as many times as you need

Course curriculum

    1. Course Outline

      FREE PREVIEW

    1. Introduction

    2. Background on Risk Management

    3. Quiz 1

    4. Risk Management Process

    5. Quiz 2

    6. Practical implementation 1

    7. Quiz 3

    8. Practical implementation 2

    9. Quiz 4

    10. Practical implementation 3

    11. Quiz 5

    12. Key Takeaways

    1. QMS, What, Why, When and How

    2. Quiz 1

    3. Medical Devices Classification and Conformity Assessment Routes

    4. Quiz 2

    5. ISO 13485: a brief introduction

    6. Quiz 3

    7. ISO 13485: the requirements

    8. Quiz 4

    9. Quality Management Process, a process-based approach

    10. Quiz 5

    11. Quality Management Process, a risk-based approach

    12. Quiz 6

    13. Obligations of the Manufacturer

    14. Quiz 7

    15. International Landscape

    16. Practical Implementation of QMS

    17. Quiz 8

    18. Concluding Remarks

    19. Quiz 9

    1. Introduction

      FREE PREVIEW

    2. Background

    3. Quiz 1

    4. Design Control 1

    5. Design Control 2

    6. Quiz 2

    7. Practical Implementation 1

    8. Practical Implementation 2

    9. Quiz 3

    10. Key Takeaways

    11. Quiz 4

    1. Introduction

    2. Quiz 1

    3. The patient is the customer

    4. Quiz 2

    5. Management oversight of quality

    6. Quiz 3

    7. Process performance and product quality monitoring (PPPQM)

    8. Quiz 4

    9. The management drives quality culture

    10. Quiz 5

    11. Top management commitment to quality 1

    12. Quiz 6

    13. Top management commitment to quality 2

    14. Quiz 7

    15. Organizational structure, responsibility, authority, resources

    16. Quiz 8

    17. Management reviews

    18. Quiz 9

    19. Resource management

    20. Quiz 10

    21. Infrastructure

    22. Quiz 11

    23. Work environment

    24. Quiz 12

    1. Regulatory background

    2. Quiz 1

    3. Basic concepts

    4. Quiz 2

    5. Step-by-step execution of a clinical evaluation

    6. Quiz 3

    7. Data identification, appraisal and analysis

    8. Quiz 4

    9. Clinical Evaluation Report

    10. Quiz 5

About this course

  • CHF399.00
  • 92 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 123 lessons of 5 to 15 minutes each. If you spend 1-2 hours per day on the course expect to complete it in 10 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.

Because Quality Starts with Education

Empower Your Innovation with Expert Guidance. Use code "confinis25" and get a 25% discount!

Enroll today