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dc.contributor.editorBergmann, Jeroen
dc.date.accessioned2022-05-06T11:24:45Z
dc.date.available2022-05-06T11:24:45Z
dc.date.issued2022
dc.identifierONIX_20220506_9783036538938_119
dc.identifier.urihttps://directory.doabooks.org/handle/20.500.12854/81053
dc.description.abstractRegulations 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.
dc.languageEnglish
dc.subject.classificationbic Book Industry Communication::T Technology, engineering, agriculture::TB Technology: general issues
dc.subject.classificationbic Book Industry Communication::T Technology, engineering, agriculture::TB Technology: general issues::TBX History of engineering & technology
dc.subject.othermedical technology
dc.subject.otherdigital healthcare
dc.subject.otherdata science
dc.subject.otherregulations
dc.subject.othermachine learning
dc.subject.othersoftware
dc.subject.othermedical device regulations
dc.subject.otherhealthcare provider
dc.subject.othersoftware as medical device
dc.subject.othertechnology translation
dc.subject.otherquality management system
dc.subject.otherlaw
dc.subject.othermedical devices
dc.subject.otherregulatory data science
dc.subject.othernatural language processing
dc.subject.otherlinguistic analysis
dc.subject.otheroptimisation
dc.subject.othermedical device
dc.subject.otherecodesign
dc.subject.otherenvironmental impact
dc.subject.otherclassification
dc.subject.otherhealthcare
dc.subject.otherinnovation
dc.subject.otherregulation
dc.subject.otherdecision tree complexity
dc.subject.othern/a
dc.titleRegulatory Data Science for Medical Devices
dc.typebook
oapen.identifier.doi10.3390/books978-3-0365-3894-5
oapen.relation.isPublishedBy46cabcaa-dd94-4bfe-87b4-55023c1b36d0
oapen.relation.isbn9783036538938
oapen.relation.isbn9783036538945
oapen.pages76
oapen.place.publicationBasel


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