IEC 62304 Audit Report Template | Medical Device Software Lifecycle | Editable Word PDF Internal Audit Checklist

IEC 62304 audits require clear documentation of software lifecycle compliance, risk-based development controls, verification & validation evidence, configuration management, and CAPA—because medical device software compliance depends on consistent, traceable audit reporting. This IEC 62304 Audit Report Format helps you streamline the audit process by capturing audit scope, findings, evidence, nonconformities, and corrective actions in one structured report—so your audit reporting stays professional, complete, and audit-ready.

This is a ready-to-use, professionally designed, and fully customizable audit report created to streamline your audit process. It supports internal audits, supplier audits, and compliance readiness by providing a standardized structure aligned with IEC 62304 expectations for software development and maintenance. Everything is organized to help auditors document checks faster, reduce reporting gaps, and close findings with clear ownership and timelines.

Whether you audit SDLC processes, software safety classification, requirements/design controls, V&V activities, problem resolution, or release management, this format supports stronger compliance documentation and smoother management review for regulatory readiness.

What’s Included:

• Audit cover page and report header (product/site, audit type, date, auditor details)
• Audit scope, objectives, criteria, and IEC 62304 reference section
• Software product overview (version, release, intended use, safety class—customizable)
• Lifecycle process audit sections (planning, development, maintenance)
• Requirements, architecture/design, and traceability evidence fields
• Verification & validation evidence checklist (test protocols, reports, defects—optional)
• Configuration management and change control verification section
• Problem resolution / defect management review fields (CAPA linkage optional)
• Nonconformity/observation log with classification fields (customizable)
• CAPA section (root cause, corrective action, owner, target date, verification)
• Closing meeting summary, audit conclusion, management sign-off, follow-up timeline

Key Benefits:

• Streamlines IEC 62304 audit reporting with a standardized, ready-to-use format
• Improves software compliance readiness with clause-wise evidence documentation
• Reduces reporting time with structured SDLC, V&V, and traceability sections
• Supports faster CAPA closure with clear ownership and due dates
• Strengthens traceability between requirements, tests, defects, and fixes
• Improves audit trail quality for internal reviews and external assessments
• Fully customizable for different software classes, products, and lifecycle scope
• Ideal for internal audits, supplier audits, and medical device software readiness

Get your IEC 62304 Audit Report audit report format today and streamline your audit process.