Regulatory Data Science for Medical Devices

Regulations that cover the legal obligations that manufacturers are bound to are essential for keeping the general public safe. Companies need to follow the regulations in order to bring their products to market. A good understanding of the regulations and the regulatory pathway defines how fast and...

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Opis bibliograficzny
Format: Online
Język:angielski
Wydane: MDPI - Multidisciplinary Digital Publishing Institute 2022
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Dostęp online:ONIX_20220506_9783036538938_119
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_version_ 1869527906768650240
collection Directory of Open Access Books
description Regulations that cover the legal obligations that manufacturers are bound to are essential for keeping the general public safe. Companies need to follow the regulations in order to bring their products to market. A good understanding of the regulations and the regulatory pathway defines how fast and at what cost the manufacturer can introduce innovations to the market. Regulatory technology and data science can lead to new regulatory processes and evidence in the medical field. It can equip stakeholders with unique tools that can make regulatory decisions more objective, efficient, and accurate. This book describes the latest research within the broader domain of Medical Regulatory Technology (MedRegTech). It covers concepts such as the complexity and user-friendliness of medical device regulations, novel algorithms for regulatory navigation, descriptive datasets from a health service provider, regulatory data science techniques, and considerations of the environmental impacts within a national health service. This book brings all these aspects together to offer an introduction into MedRegTech research. In the long term, these technologies and methods will help optimize the regulatory strategy for individual healthcare innovations and revolutionize the way we engage with regulatory services.
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language eng
publishDate 2022
publishDateRange 2022
publishDateSort 2022
publisher MDPI - Multidisciplinary Digital Publishing Institute
publisherStr MDPI - Multidisciplinary Digital Publishing Institute
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spelling doab-20.500.12854ir-810532024-04-11T15:11:17Z Regulatory Data Science for Medical Devices Bergmann, Jeroen medical technology digital healthcare data science regulations machine learning software medical device regulations healthcare provider software as medical device technology translation quality management system law medical devices regulatory data science natural language processing linguistic analysis optimisation medical device ecodesign environmental impact classification healthcare innovation regulation decision tree complexity n/a thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues::TBX History of engineering and technology Regulations that cover the legal obligations that manufacturers are bound to are essential for keeping the general public safe. Companies need to follow the regulations in order to bring their products to market. A good understanding of the regulations and the regulatory pathway defines how fast and at what cost the manufacturer can introduce innovations to the market. Regulatory technology and data science can lead to new regulatory processes and evidence in the medical field. It can equip stakeholders with unique tools that can make regulatory decisions more objective, efficient, and accurate. This book describes the latest research within the broader domain of Medical Regulatory Technology (MedRegTech). It covers concepts such as the complexity and user-friendliness of medical device regulations, novel algorithms for regulatory navigation, descriptive datasets from a health service provider, regulatory data science techniques, and considerations of the environmental impacts within a national health service. This book brings all these aspects together to offer an introduction into MedRegTech research. In the long term, these technologies and methods will help optimize the regulatory strategy for individual healthcare innovations and revolutionize the way we engage with regulatory services. 2022-05-06T11:24:45Z 2022-05-06T11:24:45Z 2022 book ONIX_20220506_9783036538938_119 9783036538938 9783036538945 https://directory.doabooks.org/handle/20.500.12854/81053 eng image/jpeg Attribution 4.0 International https://mdpi.com/books/pdfview/book/5395 https://mdpi.com/books/pdfview/book/5395 MDPI - Multidisciplinary Digital Publishing Institute 10.3390/books978-3-0365-3894-5 10.3390/books978-3-0365-3894-5 46cabcaa-dd94-4bfe-87b4-55023c1b36d0 9783036538938 9783036538945 76 Basel open access
spellingShingle medical technology
digital healthcare
data science
regulations
machine learning
software
medical device regulations
healthcare provider
software as medical device
technology translation
quality management system
law
medical devices
regulatory data science
natural language processing
linguistic analysis
optimisation
medical device
ecodesign
environmental impact
classification
healthcare
innovation
regulation
decision tree complexity
n/a
thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues
thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues::TBX History of engineering and technology
Regulatory Data Science for Medical Devices
title Regulatory Data Science for Medical Devices
title_full Regulatory Data Science for Medical Devices
title_fullStr Regulatory Data Science for Medical Devices
title_full_unstemmed Regulatory Data Science for Medical Devices
title_short Regulatory Data Science for Medical Devices
title_sort regulatory data science for medical devices
topic medical technology
digital healthcare
data science
regulations
machine learning
software
medical device regulations
healthcare provider
software as medical device
technology translation
quality management system
law
medical devices
regulatory data science
natural language processing
linguistic analysis
optimisation
medical device
ecodesign
environmental impact
classification
healthcare
innovation
regulation
decision tree complexity
n/a
thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues
thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues::TBX History of engineering and technology
topic_facet medical technology
digital healthcare
data science
regulations
machine learning
software
medical device regulations
healthcare provider
software as medical device
technology translation
quality management system
law
medical devices
regulatory data science
natural language processing
linguistic analysis
optimisation
medical device
ecodesign
environmental impact
classification
healthcare
innovation
regulation
decision tree complexity
n/a
thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues
thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues::TBX History of engineering and technology
url ONIX_20220506_9783036538938_119