Agile ALM- Software in Medical Software Development
Date: 19. February 2014
Place: NH München Dornach am MCC
Intland’s speaker: Rico Unger, Medical Expert
Agile as a series of principles, values, techniques and frameworks can be applied in software development to increase team performance. Medical Device development teams are faced with increased software complexity today when developing quality devices. Application Lifecycle Management tools play a significant role in the management of highly standardized software development process, ensuring traceability, and systematic management of risk. In the medical industry IEC 62304 international regulation is a mandatory standard that all manufacturers of medical devices must comply with. codeBeamer is a full ALM solution that manages the whole development lifecycle from Requirements Management, across Software Development, to Test and Quality Assurance Management. codeBeamer has an agile layer that provides a toolset for the implementation of Scrum and Kanban methods. codeBeamer medical project has been prepared for manufacturers of medical devices as a customized template for IEC 62304 to ensure agility across the application management lifecycle.
codeBeamer Medical project contains specific medical trackers for requirements management, specific risk tracker and risk management workflow; furthermore a medical wiki, with all elements that are required by the IEC 62304 standard including the Traceability Matrix. The Medical Document Management has been equipped with template documents, process descriptions based on the codeBeamer ALM. It ensures base lining and versioning of all artifacts, and provides full traceability on development and IT operations.
By using agile ALM software for medical software development the following benefits can be achieved:
- Reduce effort to customize ALM tools to be compliant with standards (e.g. IEC62304, ISO standards for medical, and FDA regulations),
- Import domain knowledge therefore gain quicker roll out,
- Implement agile practice to increase efficiency and reduce time to market,
- Keep flexibility by customizable projects and workflows to match with internal rules and processes.