Conference
Fda: Between Process & Product Evaluation
Abstract
Several institutions and agencies around the world, from both the private and public sectors, have adopted the practice of software validation and certification to ensure higher levels of confidence in software. The US Food and Drug Administration (FDA) is one of these organisations. The FDA has published several guidance documents concerning the validation of medical device software. In its guidance documents for both the medical software …
Authors
Abdeen MM; Kahl W; Maibaum T
Pagination
pp. 181-186
Publisher
Institute of Electrical and Electronics Engineers (IEEE)
Publication Date
June 1, 2007
DOI
10.1109/hcmdss-mdpnp.2007.6
Name of conference
2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability (HCMDSS-MDPnP 2007)