Electronic document control

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

  • Comprehensive FDA Pathway Guidance

    Gain a clear understanding of 510(k), PMA, and De Novo pathways, helping you determine the best regulatory strategy for your medical device.

  • Practical Submission Insights

    Learn how to classify devices, prepare submissions, and meet FDA documentation requirements to streamline approval processes.

  • Regulatory Compliance Confidence

    Master key compliance strategies, risk management approaches, and FDA expectations to ensure a smooth market entry and avoid common pitfalls.

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 course

  • Follow lessons as many times as you need

Course curriculum

    1. 510(k)

    2. Quiz 1

    3. Other Pathways

    4. Quiz 2

About this course

  • CHF69.00
  • 4 lessons
  • quiz at the end of the curse
  • 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 for a total of 1 hour plus the final quiz.

  • 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.