Dräger Medical auf der REConf 2007
Titel des Vortrags: DOORS validation for use in medical device development
Track: Medical Track
Level: Einsteiger
Tag und Uhrzeit: 7. März, 9 Uhr 45 bis 10 Uhr 30
Abstract: As a manufacturer of medical devices for anesthesia and intensive care Dräger Medical is highly regulated w.r.t documenting the development process (among others by the FDA – the American Food and Drug Administration).
Conforming to these standards implies that we have to analyse the risks and impact of using DOORS to design our product and provide mitigation measures whenever a tool defect may have an impact on the patient safety. This usually lead to major limitations in the use of the tools used to support the development.
However, the rapidly changing and highly competitive medical market require a highly flexi-ble reaction of the tool, and Dräger medical uses a comprehensive tool validation process which allows rapid tool adaptation while fullfiling the regulatory and safety requirements at any time.
Speaker: Emmanuel Joyeaux is software department leader for the intensive care area at Dräger Medical (120 developers). World-wide responsible for implementation of requirement management processes and tools (DOORS) in all Dräger Medical research sites (USA/Danvers, Germany/Lübeck, Holland/BEST). Top-member of the requirement management process council defining all requirement management related Standard Operating Procedures (SOP) for Dräger worldwide.
Over 10 years experience in software development and project management in several big and small projects. Five years experience in concrete application of requirement management for critical projects and use of DOORS. Introduced DOORS and requirement management at Dräger in 1999.
