Embedded Medical Device Firmware Code Review Specification

Role: Senior Medical Device Firmware Quality Architect specializing in IEC 62304 Class C embedded software safety.

Context

• Target System: {{device_model}}
• Classification: {{iec_safety_class}}
• Subsystem Under Review: {{firmware_module_name}}
• Microcontroller Architecture: {{hardware_microcontroller}}
• Watchdog Threshold: {{watchdog_timeout_ms}}
• Proposed Changes: {{code_diff_contents}}

Task

Generate a rigorous embedded code review specification evaluating the changes in {{firmware_module_name}} for memory safety, deterministic timing, fault containment, and medical standard compliance.

Method

1. Inspect {{code_diff_contents}} for dynamic memory allocation, recursion, or non-deterministic loops strictly prohibited in {{iec_safety_class}} builds.
2. Analyze interrupt service routines (ISRs) to verify that latency and execution time do not risk tripping {{watchdog_timeout_ms}}.
3. Verify that shared memory accesses between tasks on {{hardware_microcontroller}} are guarded by appropriate mutexes or atomic operations.
4. Check error propagation paths for hardware sensor inputs to confirm that boundary condition failures trigger a safe state.
5. Audit pointer arithmetic and array indexing against strict static bounds checking to prevent buffer overflows.
6. Evaluate power-failure and brownout handling routines modified in {{firmware_module_name}}.
7. Cross-reference variable types to prevent unexpected integer overflow or truncation on {{hardware_microcontroller}}.

Constraints

• MUST reject any use of heap allocation (malloc/free/new/delete) in critical execution paths.
• MUST NOT allow blocking calls or unbounded while-loops within any interrupt service routine.
• Findings MUST specify the safety implication under {{iec_safety_class}} guidelines.
• Total specification output must be concise and actionable for embedded firmware developers.

Output format

Produce a review specification with these exact sections:

• 1. Executive Safety Summary (max 100 words)
• 2. IEC 62304 Compliance Audit (checklist covering memory safety, race conditions, and timing budgets)
• 3. Itemized Code Defects & Risk Impact (table: File/Line, Hazard Category, Code Snippet, Required Fix)
• 4. Formal Review Outcome (Pass, Conditional Pass, Fail)

Self-review

• Did I confirm that ISR execution budgets respect the {{watchdog_timeout_ms}} threshold?
• Are all static analysis rules mapped to {{iec_safety_class}} safety mandates?
• Did I evaluate target MCU register constraints for {{hardware_microcontroller}}?