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#

Document

Abbreviation

Purpose

Primary Audience

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

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

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#