When is Software a Medical Device? Understanding and Determining the 'Intention' and Requirements for Software as a Medical device in EU law.
Kaspar Rosager LudvigsenShishir NagarajaAngela DalyPublished in: CoRR (2022)
Keyphrases
- software tools
- medical devices
- hardware design
- software systems
- software maintenance
- medical domain
- computer systems
- software development
- source code
- user interface
- requirements engineering
- software package
- software design
- software projects
- tool support
- development lifecycle
- design patterns
- medical data
- medical diagnosis
- real time
- life cycle
- software architecture
- data acquisition
- medical imaging
- software engineering
- website
- information systems