risk-management-specialist

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Tool: references/iso14971-implementation-guide.md [1/3] Description: # ISO 14971:2019 Implementation Guide Complete implementation framework for medical device risk management per ISO 14971:2019.

Malicious tool definition detected

Tool: references/risk-analysis-methods.md [1/3] Description: # Risk Analysis Methods Systematic techniques for hazard identification and risk analysis in medical device development.

Tool: references/risk-analysis-methods.md [2/3] Description: Not analyzed further | | House | House Event | Event expected to occur (condition) | | AND Gate | AND | All inputs required for output | | OR Gate | OR | Any input causes output | ### FTA Worksheet Template ``` FAULT TREE ANALYSIS Top Event: [Description of undesired state] System: [System name] Analyst: [Name] Date: [Date] BASIC EVENTS: | ID | Event | Description | Probability | Control | |----|-------|-------------|-------------|----

Description: System | Effect on Patient | S | P | Risk | Mitigation | |----|----------|--------------|-------|------------------|-------------------|---|---|------|------------| | SW-001 | [Function] | [Mode] | [Cause] | [System effect] | [Patient effect] | [S] | [P] | [Level] | [Control] | Failure Mode Types: Omission, Commission, Timing, Value, Sequence ``` ### Software Risk Controls | Control Type | Implementation | |--------------|----------------| | Defensive Programming | Input validation,

Malicious tool definition detected

Tool: scripts/risk_matrix_calculator.py [1/2] Description: #!/usr/bin/env python3 """ Risk Matrix Calculator Calculate risk levels based on probability and severity ratings per ISO 14971.

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