Medical Device Software IEC 62304 Code Review Plan

Role: Principal Medical Device Software Quality Engineer with deep expertise in IEC 62304, FDA 21 CFR Part 820, and safety-critical embedded architecture.

Context

• Medical Device Name: {{medical_device_name}}
• Regulatory Software Safety Class: {{regulatory_class}}
• Primary Programming Language & Framework: {{codebase_language}}
• Audit Findings Summary: {{audit_findings_summary}}
• Quality Management System Standard: {{quality_management_system}}
• Regulatory Submission Deadline: {{target_submission_deadline}}

Task

Produce a phased, audit-ready code review remediation plan that systematically resolves outstanding static analysis and peer review defects across the {{medical_device_name}} codebase while guaranteeing compliance with {{quality_management_system}} before {{target_submission_deadline}}.

Method

1. Analyze the defect profile in {{audit_findings_summary}} against safety requirements dictated by {{regulatory_class}}.
2. Segment the {{codebase_language}} codebase into risk-isolated architectural modules to isolate safety-critical routines.
3. Establish coding standard rulesets (e.g., MISRA, CERT C/C++) tailored to address specific static analysis failures.
4. Design a prioritized work breakdown schedule sorting remediation tasks by hazard severity and architectural dependency.
5. Define standardized pull request approval requirements, code coverage gates, and verification criteria for every remediated unit.
6. Formulate unit and integration re-test protocols to prove bug eradication without introducing behavioral regressions.
7. Establish traceability linking each code remediation commit back to software risk mitigation IDs in the hazard analysis file.

Constraints

• MUST align all code review criteria with the designated {{regulatory_class}} risk profile.
• MUST NOT permit pull request merges without automated static analysis pass reports and dual-peer signoff.
• Every remediation task must identify explicit technical owners and verification artifacts.
• Keep all scheduling milestones anchored strictly before {{target_submission_deadline}}.

Output format

1. Executive Summary & Defect Risk Matrix (150-200 words)
2. Phased Remediation Work Breakdown (3 chronological phases with duration and tasks)
3. Pull Request Review & Gatekeeping Protocol (5 mandatory acceptance criteria)
4. Regulatory Traceability & QMS Signoff Table (5 columns: Defect ID, Unit, Safety Impact, Reviewer, Artifact)

Self-review

• Confirm all 6 variables are seamlessly integrated into the plan context and deliverables.
• Verify the method steps specifically address the defect types outlined in {{audit_findings_summary}}.
• Ensure remediation phases fit within the timeframe leading up to {{target_submission_deadline}}.