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Process

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.

Methodologies

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Scaled Agile Framework

Scaled Agile Framework (SAFe) enables lean-agile software development practices at the enterprise level.

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Agile

AGILE software development where requirements and solutions evolve through the collaborative effort of developer and client reducing project risks and effectively managing changes.

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Scrum

Scrum Framework for new-development projects ensures expedited time to market while maintaining high quality deliverables.

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kanban

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.

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Extreme programming

Extreme Programming (XP) maintains the right level of quality encouraging fast feedback through continuous integration, automation and peer reviews.

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Unified Process

Unified Process (UP) addresses the compliance requirements and improves predictability.

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devops

DevOps is utilized across all projects to ensure frequent deployments, increasing quality and provide a mechanism for plugging automation activities.

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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.

Regulatory Standards

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ISO

ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes

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IEC

IEC 62304:2006/Amd 1:2015 Medical device software -- Software life cycle processes

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FDA

FDA 21 CFR Part 11
FDA Medical Device Cybersecurity Draft Guidance

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AAMI

Association for the Advancement of Medical Instrumentation | AAMI TIR45:2012