.. _tech-doc: Technical Documentation ======================== .. note:: This section is a work in progress. Content, requirement IDs, and diagrams will keep evolving alongside the ScanHub / A4IM development. Purpose ------- This chapter collects the technical and regulatory documentation for the ScanHub platform and the A4IM MRI scanner it powers. The documents follow a standard medical-device software documentation trail that translates stakeholder needs into product requirements, software requirements, and finally the software architecture that implements them. Document Overview ------------------ .. list-table:: :header-rows: 1 :widths: 12 15 43 30 * - Document - Abbreviation - Purpose - Primary Audience * - :doc:`Product Requirement Specification ` - PRS - Captures stakeholder and user needs and turns them into prioritized product-level requirements. Serves as the design input for the SWRS. - Product management, regulatory affairs * - :doc:`Software Requirements Specification ` - SWRS - Derives concrete, verifiable functional and non-functional software requirements from the PRS, together with representative usage scenarios and device-communication data models. - Software engineers, test engineers, quality assurance * - :doc:`Software Architecture Design Description ` - SWAD - Describes how the software is structured — its components, layers, and deployment context — to satisfy the requirements defined in the SWRS. - Developers, architects, integration and test teams Traceability ------------ Each need in the PRS is assigned a unique ``PRS_xxxx`` ID. Every functional requirement in the SWRS references the ``PRS_xxxx`` ID it originates from in its *Reference/Traceability* column, and each functional requirement carries its own ``A4IM_FR_xxx`` ID. This creates an auditable chain from a stakeholder need, through a product requirement, to a verifiable software requirement. The SWAD in turn maps requirements onto the software components responsible for implementing them. Scope ----- Together, the documents in this chapter define and describe: - Acquisition and processing of MRI data. - User interface and interaction mechanisms for medical professionals. - Integration with healthcare facility systems, including patient management and data storage solutions. - Compliance with healthcare regulations and standards for data protection, privacy, and security. - System performance, reliability, and maintenance requirements. - Safety measures and risk mitigation strategies relevant to software operation. References ---------- - Product Requirement Specification (PRS) for the A4IM scanner, detailing the expectations and needs from a product standpoint. - System Requirements Specification (SRS) for the A4IM scanner, outlining the system-level requirements the software must meet to ensure compatibility and performance within the MRI system. - Risk Assessment Worksheet, identifying potential risks associated with the software and the necessary mitigations to ensure patient and operator safety. .. note:: Document numbers and versions for the SRS and Risk Assessment Worksheet will be added once those documents are finalized. Content ------- .. toctree:: :maxdepth: 1 techdoc_prs techdoc_swrs techdoc_swad