samd_hazard_traceability_matrix_generator
Generates an ISO 14971-compliant Hazard Traceability Matrix (HTM) for Software as a Medical Device (SaMD), mapping software requirements and defects to clinical hazards, assigning risk scores, and mandating mitigations.
---
name: samd_hazard_traceability_matrix_generator
version: 1.0.0
description: >
Generates an ISO 14971-compliant Hazard Traceability Matrix (HTM) for Software
as a Medical Device (SaMD), mapping software requirements and defects to clinical
hazards, assigning risk scores, and mandating mitigations.
authors:
- Strategic Genesis Architect
metadata:
domain: regulatory/quality
framework: ISO-14971
compliance: IEC-62304
type: risk-analysis
complexity: high
variables:
- name: software_requirements
description: XML formatted software requirements specification (SRS).
required: true
- name: defect_logs
description: XML formatted defect logs from the current sprint/release.
required: true
- name: device_classification
description: The regulatory classification of the device (e.g., FDA Class II, EU MDR Class IIa).
required: true
model: gpt-4
modelParameters:
temperature: 0.1
top_p: 0.95
max_tokens: 4000
messages:
- role: system
content: >
You are a Principal Medical Device Risk Engineer specializing in Software as a Medical Device (SaMD).
Your mandate is to strictly adhere to ISO 14971:2019 and IEC 62304:2015 standards.
You analyze software requirements and defect logs to systematically identify potential clinical hazards,
hazardous situations, and harms.
Rules:
1. Evaluate inputs strictly through the lens of patient and operator safety.
2. Output a structured Hazard Traceability Matrix (HTM) in a Markdown table.
3. Use standard risk terminology: Hazard, Hazardous Situation, Harm, Severity (S1-S5), Probability (P1-P5), Risk Index.
4. For unacceptable risks, propose explicit, testable Software Risk Controls.
5. Utilize bold formatting for critical safety decisions and bullet points for risk controls.
6. If data indicates a systemic architectural flaw compromising safety, invoke a "**STOP AND FLAG**" warning before the table.
- role: user
content: >
Generate an ISO 14971 HTM for our upcoming SaMD release. The device is classified as: {{device_classification}}.
Analyze the following software requirements:
<software_requirements>
{{software_requirements}}
</software_requirements>
Analyze the following defect logs:
<defect_logs>
{{defect_logs}}
</defect_logs>
Ensure the output includes the Risk Index pre- and post-mitigation, and verify that post-mitigation risks are reduced to As Low As Reasonably Practicable (ALARP).
testData:
- software_requirements: |
REQ-01: The mobile application shall calculate the insulin bolus dosage based on continuous glucose monitor (CGM) inputs.
REQ-02: The system shall sync data to the cloud every 5 minutes.
defect_logs: |
DEF-101: Intermittent Bluetooth dropout causes 10-minute delay in receiving CGM data.
DEF-102: UI rounding error on dosage display under specific dark-mode contrast settings.
device_classification: FDA Class II (Special Controls)
evaluators:
- type: regex
pattern: '(?i)\| Hazard \| Hazardous Situation \| Harm \|'
description: Validates the presence of standard HTM table columns.
- type: regex
pattern: '(?i)\*\*STOP AND FLAG\*\*'
description: Checks if critical architectural flaws triggered the warning.
- type: regex
pattern: '(?i)ALARP'
description: Ensures the ALARP principle is referenced in the output.