INVESTIGATION ON METHODS AND CHARACTERISTICS IN MEDICAL DEVICE DEVELOPMENT
Autor: | Kuhl, Juliane, Sankowski, Olga, Krause, Dieter |
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Rok vydání: | 2020 |
Předmět: |
0209 industrial biotechnology
Medical device 670: Industrielle Fertigung Computer science biomedical design Industrielle Fertigung [670] 02 engineering and technology risk management 020901 industrial engineering & automation 0203 mechanical engineering ddc:670 design methods ddc:610 Design methods Risk management business.industry medical device development General Medicine User centred design 020303 mechanical engineering & transports Medizin [610] Risk analysis (engineering) user-centred design 610: Medizin business Risk assessment Variety management Design Validation |
Zdroj: | Proceedings of the Design Society, DESIGN Conference ; (1), 1969-1978 (2020) |
ISSN: | 2633-7762 |
Popis: | A targeted development of safe medical products can be supported by design methods. This paper analyses which design methods are applied in the development of medical devices and whether they are adapted for considering medical devices’ special features (legal, human and technical issues). In particular, variety management, risk assessment and user-centered design for medical devices are examined. Typically, interdisciplinary risk assessment is methodically supported. Additionally, user-centered design methods for requirements assessment, design verification and design validation are applied. |
Databáze: | OpenAIRE |
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