Agile can give superior results for the development of infusion pumps and clinical diagnostic systems as well web sites and games.
But although Agile adoption in a regulated environment seems simple, it is not easy. It requires investment in process, true collaboration among all functions, and servant leadership from management. Agile developers need to be aware of requirements and design documentation, traceability, risk management, and technical reviews in a regulated context.
This presentation will cover those topics and others that may be new to many Agile developers:
- Mutual learning where development involves hardware and electronics
- Developing user stories for traceability
- Documenting incrementally
- Addressing safety risk management
- Planning projects via Agile-related mapping
About the Speaker:
Brian Shoemaker consults for healthcare products companies in computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation on product and internal software, developed software quality systems, and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, clinical trial software, dental prosthetics, and other regulated industries in Germany and Switzerland as well as the U.S.
Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. He has earned a Ph.D. in chemistry and achieved ASQ Software Quality Engineer certification.
