TY  - GEN
AU  - Bergmann,Jeroen
AU  - Bergmann,Jeroen
TI  - Regulatory Data Science for Medical Devices
SN  - books978-3-0365-3894-5
PY  - 2022///
CY  - Basel
PB  - MDPI - Multidisciplinary Digital Publishing Institute
KW  - Technology: general issues
KW  - bicssc
KW  - History of engineering & technology
KW  - medical technology
KW  - digital healthcare
KW  - data science
KW  - regulations
KW  - machine learning
KW  - software
KW  - medical device regulations
KW  - healthcare provider
KW  - software as medical device
KW  - technology translation
KW  - quality management system
KW  - law
KW  - medical devices
KW  - regulatory data science
KW  - natural language processing
KW  - linguistic analysis
KW  - optimisation
KW  - medical device
KW  - ecodesign
KW  - environmental impact
KW  - classification
KW  - healthcare
KW  - innovation
KW  - regulation
KW  - decision tree complexity
KW  - n/a
N1  - Open Access
N2  - 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
UR  - https://mdpi.com/books/pdfview/book/5395
UR  - https://directory.doabooks.org/handle/20.500.12854/81053
ER  -