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  4. Medical Device development, Lifecycle management, New Technologies, Patient involvement

Medical Device development, Lifecycle management, New Technologies, Patient involvement

In this course you will be able to:

  • Understand the Medical Devices development and the lifecycle management under the MDR and IVDR
  • Acquire knowledge about the new technologies in the context of Medical Devices and in vitro diagnostics (IVDs)
  • Understand the implementation of the digital health and Artificial Intelligence in Medical Devices
  • Acquire knowledge about borderline products
  • Learn about patient involvement in Medical Devices
  • Understand the patient involvement roadmap for Medical Devices development 
4 hours
EUR 8.00

EUPATI Open Classroom content is free for all learners.
At the end of each course you can test your knowledge and earn a certificate for an 8 euro administrative fee. If interested, click the button below:

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Topic outline

General

Lesson 1: Medical Device development and lifecycle management under the MDR and IVDR

100% Complete
Book
1.Medical Device development and lifecycle management under the MDR and IVDR Book
Page
2. How Medical Devices are placed on the market Page

Lesson 2: New Technologies

100% Complete
Page
1. Introduction Page
Page
2. Software and digital health Page
Page
3. Artificial Intelligence (AI) Page
Page
4. Combination products, medicinal products with an integral Medical Device (integral DDC), and medicinal products with co-packaging device Page
Page
5. Borderline products Page

Lesson 3: Patient involvement in Medical Device development

100% Complete
Page
1. Introduction Page
Page
2. Patient involvement roadmap for Medical Device development Page
Page
Additional Reading I: Examples Provided by Devices for Dignity Page
Page
Additional Reading II: Equality and inclusivity in public involvement Page
Page
Additional Reading III: Designing a neck support collar – a collaboration with people with Motor Neurone Disease Page
Page
Additional Reading IV: Children and young people at the centre of innovation development within prosthetics Page

Assessment

0% Complete
Quiz
Assessment Quiz
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