Designing safe software for medical devices

Designing safe software for medical devices

The overall approach to system and software design and software hazard management used by best-of-practice medical device developers is presented. FDA software guidance and regulations are reviewed, and the risk management model which must be technically correct to design, verify, and validate the s...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
1. Verfasser: MacKenzie, David M.
Format: Tagungsbericht
Sprache:eng
Schlagworte:
Applied computing > Life and medical sciences > Consumer health
Applied computing > Life and medical sciences > Health informatics
Computer industry
Hazards
Medical diagnostic imaging
Programming
Risk analysis
Risk management
Safety devices
Social and professional topics > Computing > technology policy
Software and its engineering > Software creation and management > Designing software > Software implementation planning > Software design techniques
Software and its engineering > Software creation and management > Software development process management
Software design
Software quality
Software safety
Online-Zugang:Volltext bestellen
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung:The overall approach to system and software design and software hazard management used by best-of-practice medical device developers is presented. FDA software guidance and regulations are reviewed, and the risk management model which must be technically correct to design, verify, and validate the software safety of a medical device is overviewed.
ISSN:0270-5257
1558-1225
DOI:10.1145/302405.302717