Special offer: 25% off!

Explore the essentials of EUDAMED, Swissdamed, and UK Device Registration in this comprehensive course. Designed for regulatory professionals and compliance managers, this course offers practical insights into managing regulatory data, navigating submission processes, and meeting the specific requirements of the EU, Swiss, and UK markets. Learn how to effectively handle UDI/Device Registration, data exchange, and adapt to regional database systems to streamline your compliance strategy and ensure market access. To celebrate our launch, we’re offering a special 25% discount for a limited time! Use code: EUREG25 at checkout and start mastering regulatory data management today. Enroll now to stay ahead in the evolving landscape of global device registration!

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Quality Management System in the cloud

The course is part of the confinis' series  of learning tools 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

  • Regulatory Compliance Essentials

    Understand the critical requirements for EUDAMED, Swissdamed, and UK device registration, ensuring your medical devices meet regional and global standards.

  • Efficient Data Management

    Learn practical strategies for UDI registration, data exchange, and utilizing testing environments like the EUDAMED playground to streamline regulatory submissions.

  • Market Access Strategies

    Gain actionable insights into navigating unique compliance pathways for Switzerland and the UK to secure and maintain market access effectively.

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 confinis certificate on cybersecurity for medical devices.

  • 1 hour of lessons

  • 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. EUDAMED actors and operators

    2. Quiz 1

    3. UDI/Devices Registration

    4. Quiz 2

    5. Data Exchange

    6. Quiz 3

    7. EUDAMED playground

    8. Quiz 4

    9. Swissdamed

    10. Quiz 5

    11. UK Device Registration

    12. Quiz 6

About this course

  • CHF69.00
  • 13 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 6 lessons of 5 to 15 minutes each.

  • 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 "EUREG25" and get a 25% discount!

Enroll today