AGILE SOFTWARE DEVELOPMENT PROCESS
Combining AGILE with Scrum and Kanban enables a customized development style to meet individual client needs
SMEDIX uses a hybrid AGILE delivery framework, that combines practices from multiple methodologies developed during years of experience in compliance within an FDA regulated environment.
Per the Association for the Advancement of Medical Instrumentation | AAMI TIR45:2012:
- AGILE can bring value to medical device software.
- AGILE can be adapted to the unique needs of medical software.
- Apply the values of AGILE in a way that enhances a robust quality management system (QMS).
- Apply the practices of AGILE within the context of an established quality management system.
- Set the correct expectations by defining the software development lifestyle model.
- Establish robust change management systems to manage and mitigate risks associated with rapid change