Title
Adopting Agile in an FDA Regulated Environment
Abstract
This paper is an experience report describing Abbott’s adoption of agile software development practices in its molecular diagnostics division. We will compare two medical device projects; one before agile and one after. Both of these projects required submission to the FDA (the U.S. Food and Drug Administration). We will describe the adoption of agile practices from realization of the need to the selection of a mentor to implementation and fine-tuning and finally to results and lessons learned. This experience has convinced us that an agile approach is the approach best suited to development of FDA-regulated medical devices.
Year
DOI
Venue
2009
10.1109/AGILE.2009.50
AGILE
Keywords
Field
DocType
agile approach,molecular diagnostics division,agile software development practice,medical device project,agile practice,fda regulated environment,experience report,u.s. food,drug administration,fda-regulated medical device,software development,software engineering,fda,agile,agile software development,molecular diagnostics
Pharmaceutical industry,Systems engineering,Agile Unified Process,Computer science,Lean software development,Extreme programming practices,Agile usability engineering,Agile software development,Empirical process (process control model),Software development
Conference
Citations 
PageRank 
References 
16
1.26
1
Authors
4
Name
Order
Citations
PageRank
Rod Rasmussen1182.00
Tim Hughes2543.14
J. R. Jenks3161.26
John Skach4161.26