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Rommana ALM for Medical Devices

Rommana ALM was designed to support and enforce many standards and processes required by IEC 62304,
IEC 60601, ISO 14971 and other ISO/IEC/FDA standards. Rommana ALM for medical devices suports the following features:

  • Enforces complete and detailed product requirements for all types of requirements including hardware,
    firmware, software, quality, performance, safety, and usability. All requirements are treated seamlessly.
  • Allows defining implementation actions for safety, performance, and usability requirements and tracks
    those actions throughout the development process
  • Provides complete traceability of all requirements to code modules and design components
  • Allows the enforcement of e-Signature on reviewing, approving, and editing project entities
  • Allows for defining and maintaining Failure Mode and Effect Analysis (FMEA)
  • Provides complete traceability of all requirements to test scenarios, test cases and test sets
  • The Requirement/Test Coverage matrix guarantees that every requirement had the adequate number of
    test cases and it shows the readiness of the feature for release as well as remaining tests
  • Allows for defining the dependencies between different requirements
  • Allows all team members and customers to collaborate on reviewing requirements and suggesting changes
    and adjustments to the requirements
  • All changes to any requirement are tracked through the history of a requirement
  • Allows for defining workflow to assign approval authority for all requirement and all change requests to
    the requirement and tracks the approval process
  • The Change Management component of Rommana ALM tracks major changes to requirements and the
    impact of these changes
  • The Change Management Component also maintains multiple versions of a requirement based on changes
  • Risk Management: All risks associated with any requirement are tracked throughout the development process
  • All tasks associated with the implementation of a requirement are assigned to resources and progress is
    tracked throughout the development process and beyond
  • The Document management component of Rommana ALM provides a platform for complete documents
    required by all IEC, ISO, and FDA standards