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

  • In-Depth EU MDR Clinical Evaluation Guidance

    Understand the full scope of clinical evaluation requirements under EU MDR, including literature reviews, clinical data appraisal, and CER structure.

  • Practical CER Development Skills

    Learn how to plan, write, and maintain Clinical Evaluation Reports (CERs) that meet Notified Body expectations and support conformity assessment.

  • Regulatory Confidence for Market Access

    Build the knowledge and tools needed to align with MDR compliance, reduce audit risks, and support successful EU market approval.

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 clinical evaluations for medical devices.

  • 1 hour of lessons

  • Quiz at the end of each lesson

  • Follow lessons as many times as you need

Course curriculum

    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

  • CHF250.00
  • 10 lessons
  • quiz at the end of the course
  • 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 5 lessons of 5 to 15 minutes each for a total of 1 hour plus the 5 quizzes, one per lesson.

  • 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.