Medical Devices
portes grátis
Medical Devices
Improving Health Care Through a Multidisciplinary Approach
Boccato, Carlo; Vienken, Joerg; Cerutti, Sergio
Springer Nature Switzerland AG
02/2022
275
Dura
Inglês
9783030856526
15 a 20 dias
665
Descrição não disponível.
1. Introduction (CB, SC, JV).- 1.1 How the medical devices can add value and support the health systems worldwide for present and future challenges.- 2. Role of technology in Health Care (CB, JV).- Historical background: summary of the different approaches to medicine along the times.- The technology in medicine: from the stethoscope, to the WWI innovation, to the present.- The meaning of innovation in technology and medicine.- 3. Definition and international classification of Medical Devices (SC, JV, GC).- 3.1 The medical device concept.- Medical devices and pharmaceuticals: an important difference.- The rationale behind the definition.- 3.2 Standards and regulations (ISO, AAMI (USA), MHW (Japan), MDD (Europe)).- Description and comparison among the different standards.- The rationale behind the classification.- Evaluation of risks and benefits.- Focus on EU MDR.- The impacts of classification on design and operation of medical devices.- Remarks on in-vitro diagnostics and combinationproducts.- 3.3 ICT and patient's privacy.- 3.4 Ethical aspects.- 4. Technical and operational perspective (CB, JV).- 4.1 Typical lifecycle of a medical device.- 4.2 The impact of Medical Devices in the healthcare institution.- 4.3 The need for a systemic approach.- 5. Economic Perspective (EL, SF, MdV).- 5.1 Overview.- 5.2 Value in medicine.- 5.3 Reimbursement systems.- 6. Further challenges (CB, SC, JV, SF).- 6.1 Healthcare sustainability and consequences on medical devices technology.- 6.2 Medical devices in Developing Countries.- 7. Future outlook and conclusions (CB, SC, JV).
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biomedical engineering;health economy;health care management;medical devices;medical devices directives & regulations;health care system sustainability;medical electronics
1. Introduction (CB, SC, JV).- 1.1 How the medical devices can add value and support the health systems worldwide for present and future challenges.- 2. Role of technology in Health Care (CB, JV).- Historical background: summary of the different approaches to medicine along the times.- The technology in medicine: from the stethoscope, to the WWI innovation, to the present.- The meaning of innovation in technology and medicine.- 3. Definition and international classification of Medical Devices (SC, JV, GC).- 3.1 The medical device concept.- Medical devices and pharmaceuticals: an important difference.- The rationale behind the definition.- 3.2 Standards and regulations (ISO, AAMI (USA), MHW (Japan), MDD (Europe)).- Description and comparison among the different standards.- The rationale behind the classification.- Evaluation of risks and benefits.- Focus on EU MDR.- The impacts of classification on design and operation of medical devices.- Remarks on in-vitro diagnostics and combinationproducts.- 3.3 ICT and patient's privacy.- 3.4 Ethical aspects.- 4. Technical and operational perspective (CB, JV).- 4.1 Typical lifecycle of a medical device.- 4.2 The impact of Medical Devices in the healthcare institution.- 4.3 The need for a systemic approach.- 5. Economic Perspective (EL, SF, MdV).- 5.1 Overview.- 5.2 Value in medicine.- 5.3 Reimbursement systems.- 6. Further challenges (CB, SC, JV, SF).- 6.1 Healthcare sustainability and consequences on medical devices technology.- 6.2 Medical devices in Developing Countries.- 7. Future outlook and conclusions (CB, SC, JV).
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