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
