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Medical Device development, Lifecycle management, New Technologies, Patient involvement
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1.Medical Device development and lifecycle management under the MDR and IVDR
2. How Medical Devices are placed on the market
1. Introduction
2. Software and digital health
3. Artificial Intelligence (AI)
4. Combination products, medicinal products with an integral Medical Device (integral DDC), and medicinal products with co-packaging device
5. Borderline products
1. Introduction
2. Patient involvement roadmap for Medical Device development
Additional Reading I: Examples Provided by Devices for Dignity
Additional Reading II: Equality and inclusivity in public involvement
Additional Reading III: Designing a neck support collar – a collaboration with people with Motor Neurone Disease
Additional Reading IV: Children and young people at the centre of innovation development within prosthetics
Assessment
1.Medical Device development and lifecycle management under the MDR and IVDR ►