Special offer: 25% off!

Master the transition to FDA's QMSR in this comprehensive course, designed for regulatory professionals and quality managers. Gain practical insights into aligning with ISO 13485, implementing risk-based quality systems, and navigating updated FDA requirements. Learn to manage regulatory documentation, optimize processes, and ensure seamless compliance for the U.S. market. To celebrate our course launch, we’re offering a special 25% discount for a limited time! Use code: QMSR25 at checkout to secure your spot and take the next step in quality management excellence. Enroll now to lead your organization through a successful QMSR transition!

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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

  • QMSR Transition Fundamentals

    Gain a clear understanding of the key changes in FDA’s QMSR, including ISO 13485 alignment, risk-based practices, and updated documentation requirements.

  • Streamlined Compliance Processes

    Learn practical strategies for gap analysis, supplier management, and audit preparation to ensure seamless regulatory compliance.

  • Enhanced Quality Management

    Master the implementation of risk-based, process-focused systems that drive continuous improvement and strengthen global market readiness.

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. Introduction

      FREE PREVIEW

    2. Background

    3. Understanding QMSR

    4. Core Changes

    5. ISO 13485 and QMSR

    6. How to prepare

    7. Quiz

About this course

  • CHF69.00
  • 7 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.

Because Quality Starts with Education

Empower Your Innovation with Expert Guidance. Use code "QMSR25" and get a 25% discount!

Enroll today