R-TF-012-029 Software Architecture Description
Document Information
| Field | Value |
|---|---|
| Product Name | |
| Version | |
| Prepared By | |
| Prepared Date | |
| Reviewed By | |
| Review Date | |
| Approved By | |
| Approval Date | |
| Related SRS Document |
1. Introduction
1.1 Purpose
This document describes the software architecture for the medical device software, including the high-level structure, key software components, interfaces, and design decisions. The architecture provides the framework for implementing the software requirements specified in the Software Requirements Specification (SRS).
1.2 Scope
This architecture description covers:
- High-level software architecture and system decomposition
- Software elements and their responsibilities
- Interfaces between software elements and external systems
- SOUP (Software of Unknown Provenance) components
- Data flow and control flow
- Architectural decisions and rationale
1.3 References
| Reference | Title | Version |
|---|---|---|
| R-TF-012-023 | Software Development Plan | |
| R-TF-012-028 | Software Requirements Specification | |
| R-TF-012-019 | SOUPs | |
| R-TF-013-002 | Risk Management Record |
2. Architectural Overview
2.1 System Context
[Describe the system context, including external systems, users, and interfaces]
2.2 Architectural Style
[Describe the architectural style/pattern used: microservices, layered, event-driven, etc.]
2.3 High-Level Architecture
[Provide a high-level architecture diagram showing major software elements]
3. Software Elements
3.1 Software Element Decomposition
| Software Element | Description | Responsibilities | Interfaces |
|---|---|---|---|
3.2 Software Element Details
3.2.1 [Element Name]
Description: [Detailed description of the software element]
Responsibilities:
- [Responsibility 1]
- [Responsibility 2]
Inputs: [Data inputs]
Outputs: [Data outputs]
Interfaces: [Description of interfaces with other elements]
SOUP Dependencies: [List any SOUP components used]
4. Interfaces
4.1 Internal Interfaces
4.1.1 Interface Between [Element A] and [Element B]
| Attribute | Description |
|---|---|
| Interface Type | API / Message Queue / Database / etc. |
| Protocol | REST / gRPC / AMQP / etc. |
| Data Format | JSON / XML / Binary / etc. |
| Error Handling | [Description] |
Interface Definition: [Provide detailed interface specification, including methods, parameters, return values]
4.2 External Interfaces
4.2.1 User Interface
[Description of user interface, including screens, workflows, and user interactions]
4.2.2 Hardware Interfaces
[If applicable, describe interfaces with hardware components]
4.2.3 Software Interfaces
| External System | Purpose | Interface Type | Protocol | Data Format |
|---|---|---|---|---|
4.2.4 Communication Interfaces
[Describe network communication, APIs, web services]
5. Data Architecture
5.1 Data Model
[Describe the data model, including entities, relationships, and key attributes]
5.2 Data Flow
[Describe how data flows through the system]
5.3 Data Storage
| Data Type | Storage Location | Retention Period | Backup Strategy |
|---|---|---|---|
5.4 Data Security
[Describe data encryption, access control, and security measures]
6. SOUP (Software of Unknown Provenance)
6.1 SOUP Components
| SOUP Name | Version | Purpose | Functional Requirements | Hardware/Software Requirements |
|---|---|---|---|---|
For detailed SOUP documentation, see SOUP Directory.
6.2 SOUP Risk Analysis
[Reference to risk analysis for SOUP components]
7. Risk Control Measures
7.1 Segregation for Risk Control
[If applicable for Class C software, describe segregation necessary for risk control]
7.2 Software Elements Contributing to Hazardous Situations
| Software Element | Potential Hazard | Risk Control Measure | Verification Method |
|---|---|---|---|
For detailed risk analysis, see R-TF-013-002 Risk Management Record.
8. Architectural Decisions
8.1 Key Architectural Decisions
| Decision ID | Decision | Rationale | Alternatives Considered | Trade-offs |
|---|---|---|---|---|
| AD-001 |
8.2 Technology Stack
| Layer | Technology | Version | Justification |
|---|---|---|---|
| Frontend | |||
| Backend | |||
| Database | |||
| Infrastructure |
9. Non-Functional Requirements
9.1 Performance
[Describe performance requirements and how the architecture addresses them]
9.2 Scalability
[Describe scalability considerations]
9.3 Security
[Describe security architecture and measures]
9.4 Reliability and Availability
[Describe reliability and availability considerations]
9.5 Maintainability
[Describe how the architecture supports maintenance and evolution]
10. Architecture Verification
10.1 Verification Activities
| Verification Activity | Method | Result | Reference |
|---|---|---|---|
| Consistency with requirements | Review | ☐ Pass ☐ Fail | |
| Implementation feasibility | Review | ☐ Pass ☐ Fail | |
| Maintainability assessment | Review | ☐ Pass ☐ Fail | |
| Security review | Review | ☐ Pass ☐ Fail |
10.2 Architecture Review Results
[Document the results of architecture verification activities]
11. Traceability
11.1 Requirements to Architecture Elements
| Requirement ID | Requirement Description | Architecture Element(s) |
|---|---|---|
For the traceability matrix template, see T-012-043.
12. Deployment Architecture
12.1 Deployment Environment
[Describe the deployment environment: cloud, on-premise, hybrid]
12.2 Deployment Diagram
12.3 Infrastructure Requirements
| Component | Specification | Quantity | Purpose |
|---|---|---|---|
Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Prepared By (JD-007) | |||
| Reviewed By (JD-003) | |||
| Approved By (JD-001) |
End of Software Architecture Description