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Introduction to regulatory requirements for AI-based medical devices

Categories: Introduction course
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About Course

Dear participants,

welcome to our course “Introduction to regulatory requirements for AI-based medical devices”!

We are thrilled to have you join us on exploring the use of data-driven systems with a focus on new challenges. An open mind and a curious spirit is everything you need to complete this course.

Artificial Intelligence, or AI, has become an integral part of our lives, revolutionizing industries and shaping the way we interact with technology. However, the key to unlocking its true potential lies in ensuring the requirements of AI regulations. In our modern world, where AI ranges from various sectors- namely from healthcare and technical devices to patients and users- understanding AI regulations is not only something optional, but it has become an indispensable skill. By grasping the principles behind regulations, you will position yourself as a frontrunner in the realm of safe innovation. This knowledge empowers you to contribute to the development of medical devices that follow the sectoral requirements.

Explore the regulatory requirements for AI-based medical devices
We will explore many examples of real-world use of AI in medical devices. Throughout this course, we will unravel the essential elements of the regulatory frameworks, including technical, regulative and normative considerations. To explore the practical techniques and industry’s best practices, we have included multiple perspectives that will equip you with the knowledge and skills needed to evaluate, enhance, and ensure the regulatory requirements for AI-based medical devices.

About our trainer
Dr. Prinz works at VDE on the regulatory requirements for medical devices and software. Until 2012, he was employed as group leader and quality manager in the biopharmaceutical industry. Before he served as research associate at the universities of Freiburg and Utrecht. You can reach out to via LinkedIn here.

Complete course
Our online solutions are series of courses in which you gain an overview. To get started, subscribe directly to the course and review its modules and select the one you want to start with. When you subscribe to a course, you automatically subscribe to the entire modules. It’s okay if you only want to complete one module- you can pause your learning or cancel your subscription at any time. Go to your learner dashboard to track your course enrollments and progress.

Earn a certificate
Once you have completed all modules you will receive a certificate that you can share with potential employers and your professional network.

Contact us for booking
Please reach out to our team of experienced instructors for an offer and to book the course. They are passionate about sharing their expertise and guiding you on this transformative learning journey. If you face any technical problems or have questions. Contact us via info@aiqualityhub.com!

Start the course
So, get ready to expand your horizons, challenge your intellect, and unlock the insights of AI medical regulation. You can start the class now, enjoy! Best, AI Quality & Testing Hub Team

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Course Content

Regulatory requirements for AI based medical devices in the EU

  • Click here to learn about what should be considered when it comes to medical devices
    02:43

Medical device software

Medical device risk class

Obligations of the manufacturer and product requirements

Regulatory strategy

Software life cycle and AI model development

Continuous learning medical AI systems

Risk management & cybersecurity

Usability

Clinical evaluation

Post market surveillance

Summary and final quiz