Free compliance templates
Standalone templates for risk management, SOUP tracking, and design-output documentation in medical device, aerospace, and automotive programs. Easy, free direct download. We don't even need your email.
FMEA Template
Failure Mode and Effects Analysis
ISO 14971 risk analysis with Severity × Occurrence × Detection scoring, RPN, recommended actions, mitigation tracking, and cross-references to the RTM requirements and risk register. Covers medical device, aerospace, automotive, and software contexts.
Hazard Log Template
ISO 14971 Hazard Register
Top-level hazard register for ISO 14971 risk management. Tracks hazards, hazardous situations, potential harm, initial and residual risk levels (Severity × Probability), risk control measures with type classification, verification status, and ALARP justification. Includes a 5×5 Risk Matrix tab with Acceptable / ALARP / Unacceptable levels.
Risk Management Plan Template
ISO 14971:2019 Risk Management Plan
ISO 14971:2019 compliant Risk Management Plan covering scope, roles and responsibilities, risk acceptability criteria (5×5 matrix with Acceptable / ALARP / Unacceptable), risk control verification, lifecycle review milestones, post-production monitoring, and a full traceability chain from hazard to test report. Word document (.docx).
V&V Plan Template
Verification and Validation Plan
Structured V&V Plan covering verification and validation strategy, activity tables (VER-xxx / VAL-xxx IDs), four verification methods (Test / Analysis / Inspection / Demonstration), risk control verification per ISO 14971 §5.6, RTM traceability summary, and standard-specific guidance for ISO 13485, IEC 62304, DO-178C, ISO 26262, and AS9100.
SOUP Template
Software of Unknown Provenance Register
IEC 62304 SOUP register with component name, version, supplier, license, safety class, known anomalies, anomaly evaluation, and direct requirement and test references. Use standalone or connect to RTMify Live as a read-only SOUP source.
Design BOM Template
Design Bill of Materials
Structured design-intent BOM with a Product tab and Design BOM tab. Hierarchy, quantity, supplier, part revision, and explicit requirement and test reference columns for typed trace links. Use standalone or connect to RTMify Live for BOM gaps, impact analysis, and MCP queries.
Building an ISO 14971 risk management file? The Risk Management Plan, Hazard Log, and FMEA templates above all map to specific clauses — see our ISO 14971:2019 clause-by-clause guidance for how they fit together.
More in development: Design History File, Test Case Specification, Configuration Item List, Change Impact Analysis, Requirements Review Checklist.
The core RTM template
The Requirements Traceability Matrix (RTM) template is the starting point for all six supported standards. These free templates are standalone artifacts designed to work alongside it.