LEADER 03291nam 2200649z- 450 001 9910566476203321 005 20231214133452.0 035 $a(CKB)5680000000037617 035 $a(oapen)https://directory.doabooks.org/handle/20.500.12854/81053 035 $a(EXLCZ)995680000000037617 100 $a20202205d2022 |y 0 101 0 $aeng 135 $aurmn|---annan 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aRegulatory Data Science for Medical Devices 210 $aBasel$cMDPI - Multidisciplinary Digital Publishing Institute$d2022 215 $a1 electronic resource (76 p.) 311 $a3-0365-3893-3 311 $a3-0365-3894-1 330 $aRegulations 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. 606 $aTechnology: general issues$2bicssc 606 $aHistory of engineering & technology$2bicssc 610 $amedical technology 610 $adigital healthcare 610 $adata science 610 $aregulations 610 $amachine learning 610 $asoftware 610 $amedical device regulations 610 $ahealthcare provider 610 $asoftware as medical device 610 $atechnology translation 610 $aquality management system 610 $alaw 610 $amedical devices 610 $aregulatory data science 610 $anatural language processing 610 $alinguistic analysis 610 $aoptimisation 610 $amedical device 610 $aecodesign 610 $aenvironmental impact 610 $aclassification 610 $ahealthcare 610 $ainnovation 610 $aregulation 610 $adecision tree complexity 615 7$aTechnology: general issues 615 7$aHistory of engineering & technology 700 $aBergmann$b Jeroen$4edt$01277814 702 $aBergmann$b Jeroen$4oth 906 $aBOOK 912 $a9910566476203321 996 $aRegulatory Data Science for Medical Devices$93012096 997 $aUNINA