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

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General

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After completing 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

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

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

Go to section Lesson 1: Medical Device development and lifecycle management under the MDR and IVDR
Select activity 1.Medical Device development and lifecycle management under the MDR and IVDR

1.Medical Device development and lifecycle management under the MDR and IVDR Book

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Select activity 2. How Medical Devices are placed on the market

2. How Medical Devices are placed on the market Page

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Select section Lesson 2: New Technologies

Lesson 2: New Technologies

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Select activity 1. Introduction

1. Introduction Page

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Select activity 2. Software and digital health

2. Software and digital health Page

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Select activity 3. Artificial Intelligence (AI)

3. Artificial Intelligence (AI) Page

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Select activity 4. Combination products, medicinal products with an integral Medical Device (integral DDC), and medicinal products with co-packaging device

4. Combination products, medicinal products with an integral Medical Device (integral DDC), and medicinal products with co-packaging device Page

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Select activity 5. Borderline products

5. Borderline products Page

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Select section Lesson 3: Patient involvement in Medical Device development

Lesson 3: Patient involvement in Medical Device development

Go to section Lesson 3: Patient involvement in Medical Device development
Select activity 1. Introduction

1. Introduction Page

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Select activity 2. Patient involvement roadmap for Medical Device development

2. Patient involvement roadmap for Medical Device development Page

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Select activity Additional Reading I: Examples Provided by Devices for Dignity

Additional Reading I: Examples Provided by Devices for Dignity Page

Select activity Additional Reading II: Equality and inclusivity in public involvement

Additional Reading II: Equality and inclusivity in public involvement Page

Select activity Additional Reading III: Designing a neck support collar – a collaboration with people with Motor Neurone Disease

Additional Reading III: Designing a neck support collar – a collaboration with people with Motor Neurone Disease Page

Select activity Additional Reading IV: Children and young people at the centre of innovation development within prosthetics

Additional Reading IV: Children and young people at the centre of innovation development within prosthetics Page
Select section Assessment

Assessment

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Assessment Quiz

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Receive a passing grade

Side Drawer

Side Drawer

Section outline

General

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

Lesson 2: New Technologies

Lesson 3: Patient involvement in Medical Device development

Assessment