Download - Agile development and the FDA
© Decisio Health, Inc. 2015
Decisio Health featured at FDA workshop May 10, 2015
“Your FDA clearance was featured as the paving path in regulation of clinical decision support tools in the U.S. The [FDA] regulatory attorney who was presenting on this topic explained that your clearance reflects FDA’s thinking regarding the regulation for these software tools.”
-- Anna Libman Manager Regulatory Affairs
Experien Group
© Decisio Health, Inc. 2015
Value Statement
Decisio Health provides an FDA cleared class II medical device that displays real-time actionable information with the goal of increasing clinical guideline adherence, which has been shown to improve clinical outcomes and reduce hospital costs.
© Decisio Health, Inc. 2015
Case study for Agile development of FDA regulated software
• In January 2015 Decisio Health became the first 100% Web-native software to receive FDA clearance
• There is still little guidance from the FDA in terms of what software requires FDA clearance/approval
• Our software was developed over several years utilizing Agile development practices while also maintaining FDA required quality controls and documentation
• Despite seemingly contradictory requirements, Agile practices can be utilized while creating FDA regulated software
© Decisio Health, Inc. 2015
Deliver clinical information across all hardware platforms
iPhone™, Android™ Android Tablet™, iPad™
PC/Nursing StationWall mount at Bedside