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.
Scaled Agile Framework
Scaled Agile Framework (SAFe) enables lean-agile software development practices at the enterprise level.
AGILE software development where requirements and solutions evolve through the collaborative effort of developer and client reducing project risks and effectively managing changes.
Scrum Framework for new-development projects ensures expedited time to market while maintaining high quality deliverables.
The use of Kanban for Application Management, Product Care, DevOps or IT Support activities, enables active tracking to address issues in a timely matter and in a fully transparent way.
Extreme Programming (XP) maintains the right level of quality encouraging fast feedback through continuous integration, automation and peer reviews.
Unified Process (UP) addresses the compliance requirements and improves predictability.
DevOps is utilized across all projects to ensure frequent deployments, increasing quality and provide a mechanism for plugging automation activities.
Disciplined Agile Delivery
With Disciplined Agile Delivery (DAD), we cover the full delivery lifecycle. We embrace the goal orientation approach from DAD, which empowers our teams to own their decisions and actions to reach defined project goals.
ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
IEC 62304:2006/Amd 1:2015 Medical device software -- Software life cycle processes
FDA 21 CFR Part 11
FDA Medical Device Cybersecurity Draft Guidance
Association for the Advancement of Medical Instrumentation | AAMI TIR45:2012