---
title: "Medical Device Traceability"
description: "Comprehensive guide to medical device requirements traceability for FDA, ISO 13485, IEC 62304, and ISO 14971 compliance"
---

# Medical Device Traceability

TraceRTM provides comprehensive requirements traceability management specifically designed for medical device development, meeting FDA, ISO, and IEC regulatory standards. This guide covers essential traceability practices for medical device engineers, quality assurance teams, and regulatory affairs professionals.

## Overview

Medical device development requires rigorous traceability to demonstrate compliance with regulatory requirements and ensure patient safety. TraceRTM helps organizations maintain complete traceability chains from user needs through design, verification, validation, and post-market surveillance.

### Why Traceability Matters in Medical Devices

**Regulatory Compliance**: FDA 21 CFR Part 820, ISO 13485, IEC 62304, and other regulations mandate complete traceability.

**Patient Safety**: Ensures all safety requirements are properly implemented and verified.

**Audit Readiness**: Provides inspectors with clear evidence of design controls and quality processes.

**Risk Management**: Links hazards to mitigations and verification activities per ISO 14971.

**Change Control**: Enables impact analysis when requirements or designs change.

**Design History File (DHF)**: Maintains complete documentation of the design development process.

## FDA 21 CFR Part 11 Compliance

### Electronic Records and Signatures

TraceRTM supports FDA 21 CFR Part 11 requirements for electronic records and electronic signatures in regulated environments.

#### Key Requirements

**§11.10 Controls for Closed Systems**

- **Validation**: System validation documentation demonstrating reliable operation
- **Audit Trails**: Immutable records of all requirement changes, links, and approvals
- **Access Controls**: Role-based permissions for reading, editing, and approving requirements
- **Data Integrity**: Checksums and version control prevent unauthorized modifications
- **Secure Storage**: Encrypted data storage and transmission
- **Authentication**: User authentication with password complexity requirements

**§11.50 Signature Manifestations**

- Electronic signatures include user ID, date/time stamp, and meaning (e.g., "Approved", "Reviewed")
- Signatures are permanently linked to their respective records
- Signed documents cannot be modified without breaking the signature

**§11.70 Signature/Record Linking**

- Digital signatures cryptographically bound to electronic records
- Any modification to a signed record invalidates the signature
- Complete audit trail of signature events

#### Implementation in TraceRTM

```bash
# Enable audit trail for all requirement changes
tracertm config set audit.enabled true
tracertm config set audit.retention_days 2555  # 7 years per FDA

# Configure user authentication
tracertm config set auth.password_complexity high
tracertm config set auth.session_timeout 15  # minutes

# Enable electronic signatures
tracertm config set signatures.required_for_approval true
tracertm config set signatures.algorithm SHA256-RSA
```

### Audit Trail Best Practices

**What to Capture**:
- User ID and full name
- Date and time stamp (UTC)
- Action performed (create, modify, delete, approve)
- Old and new values for modifications
- Reason for change (required for critical items)
- IP address and session information

**Retention**:
- Maintain audit trails for the lifetime of the device plus 2 years (FDA requirement)
- Implement automated archival and backup procedures
- Ensure audit records are tamper-proof and verifiable

**Review**:
- Periodic audit trail reviews by quality assurance
- Exception reports for unusual access patterns
- Management review of trend analysis

## IEC 62304 Software Lifecycle Requirements

### Software Safety Classification

IEC 62304 requires classification of software systems based on potential harm:

**Class A**: No injury or damage to health is possible

**Class B**: Non-serious injury is possible

**Class C**: Death or serious injury is possible

TraceRTM helps manage requirements across all safety classes with appropriate documentation rigor.

### Software Development Process

#### Software Requirements Analysis (5.2)

```markdown
# Example Requirement Structure

## User Requirement (UR-001)
**Description**: The device shall alarm when temperature exceeds safe limits
**Safety Classification**: Class C
**Rationale**: Prevents patient thermal injury
**Acceptance Criteria**: Alarm activates within 2 seconds of threshold breach

### Derived Software Requirements
- SWR-001: Monitor temperature sensor every 100ms
- SWR-002: Compare reading to threshold (37.5°C ± 0.1°C)
- SWR-003: Activate visual and audible alarm when exceeded
- SWR-004: Log alarm event with timestamp and temperature value

### System Requirements (Linked)
- SR-025: Temperature monitoring system
- SR-026: Alarm notification system

### Risk Analysis (Linked)
- HA-003: Overheating causing patient burn
- RM-003: Temperature monitoring with alarm
```

#### Software Architectural Design (5.3)

Link software requirements to architectural components:

```bash
# Create architectural components
tracertm item create "Temperature Monitor Module" --type architecture
tracertm item create "Alarm Controller Module" --type architecture
tracertm item create "Data Logger Module" --type architecture

# Link requirements to architecture
tracertm link create SWR-001 --to ARCH-001 --type implements
tracertm link create SWR-002 --to ARCH-001 --type implements
tracertm link create SWR-003 --to ARCH-002 --type implements
tracertm link create SWR-004 --to ARCH-003 --type implements
```

#### Software Detailed Design (5.4)

For Class B and C software, maintain detailed design documentation:

- Module interfaces and data structures
- Algorithms and control flow
- Database schemas
- Communication protocols
- Error handling strategies

#### Software Unit Implementation and Verification (5.5)

```bash
# Link source code files to requirements
tracertm item create "temp_monitor.c" --type source_code
tracertm link create SWR-001 --to CODE-001 --type implemented_by

# Link unit tests to requirements
tracertm item create "test_temp_monitor.c" --type unit_test
tracertm link create SWR-001 --to TEST-001 --type verified_by
tracertm link create TEST-001 --to CODE-001 --type tests
```

#### Software Integration and Testing (5.6)

Create integration test cases that verify interfaces between modules:

```markdown
## Integration Test: Temperature to Alarm Interface

**Test ID**: IT-042
**Objective**: Verify temperature monitor triggers alarm correctly
**Preconditions**: System in operational state, no active alarms
**Test Steps**:
1. Inject simulated temperature of 36.0°C - verify no alarm
2. Inject simulated temperature of 37.6°C - verify alarm activates
3. Verify alarm activation time < 2 seconds
4. Verify event logged with correct timestamp and value

**Requirements Verified**: SWR-001, SWR-002, SWR-003, SWR-004
**Status**: Passed
**Tester**: J. Smith
**Date**: 2024-12-06
**Evidence**: Test log file IT-042-20241206.log
```

#### Software System Testing (5.7)

System-level tests verify complete software functionality:

```bash
# Create system test plan
tracertm item create "System Test Plan v2.1" --type test_plan

# Link to all software requirements
tracertm link create TEST_PLAN-001 --to-query "type:software_requirement" --type verifies

# Track test execution
tracertm item update SYS-TEST-001 --status passed
tracertm item update SYS-TEST-001 --field evidence "Report-2024-12-06.pdf"
```

### SOUP (Software of Unknown Provenance)

For Class B and C devices, document all off-the-shelf software:

```markdown
## SOUP Item: OpenSSL Library

**Component**: OpenSSL 3.0.11
**Purpose**: Cryptographic operations for secure communication
**Functional Requirements**: Encryption, digital signatures, key exchange
**Hardware/Software Requirements**: Linux, 64-bit x86
**Known Anomalies**: CVE-2023-XXXXX (mitigated by configuration)
**Version Control**: Exact version pinned in build system
**Cybersecurity Risks**: Assessed and documented in RA-SOUP-003
**Monitoring**: Subscribe to OpenSSL security advisories
```

## ISO 13485 Quality Management Integration

### Design and Development Planning (7.3.2)

TraceRTM integrates with quality management systems to maintain design planning documentation:

```bash
# Create design plan
tracertm item create "Insulin Pump Design Plan v3.0" --type design_plan

# Define phases and milestones
tracertm item create "Phase 1: Requirements Analysis" --type phase
tracertm item create "Phase 2: Architecture Design" --type phase
tracertm item create "Phase 3: Detailed Design" --type phase
tracertm item create "Phase 4: Verification & Validation" --type phase

# Link deliverables to phases
tracertm link create PHASE-001 --to "User Requirements Spec" --type produces
tracertm link create PHASE-001 --to "Risk Analysis v1.0" --type produces
```

### Design and Development Inputs (7.3.3)

Capture all design inputs with appropriate review and approval:

- Intended use and indications for use
- User needs and stakeholder requirements
- Regulatory and standards requirements
- Risk management outputs
- Usability engineering requirements
- Previous similar designs (lessons learned)

### Design and Development Outputs (7.3.4)

Ensure outputs meet input requirements and include:

```bash
# Verify all inputs have corresponding outputs
tracertm report coverage --from design_input --to design_output

# Check for verification criteria
tracertm query "type:design_output AND missing:acceptance_criteria"

# Validate manufacturing information
tracertm link create DESIGN-OUTPUT-042 --to DMR-SPEC-007 --type manufacturing_spec
```

### Design and Development Review (7.3.5)

Schedule and document design reviews:

```markdown
## Design Review: Critical Design Review (CDR)

**Date**: 2024-12-15
**Participants**:
- Engineering Lead: Dr. A. Johnson
- Quality Assurance: M. Chen
- Regulatory Affairs: S. Patel
- Clinical Specialist: Dr. R. Williams

**Scope**: Complete architectural design for insulin delivery module

**Items Reviewed**:
- System Architecture Document v2.0
- Interface Control Document v2.0
- Risk Analysis Update v2.3
- Verification Plan v2.0

**Findings**:
1. Action Item 1: Update fail-safe mode specification (Owner: A. Johnson, Due: 2024-12-20)
2. Action Item 2: Add cybersecurity requirements (Owner: M. Chen, Due: 2024-12-18)

**Decision**: Approve with action items - Proceed to detailed design
**Signatures**: [Electronic signatures per 21 CFR Part 11]
```

### Design and Development Verification (7.3.6)

Verification confirms outputs meet input requirements:

```bash
# Generate verification matrix
tracertm report matrix \
  --rows "type:requirement" \
  --cols "type:test_case" \
  --filter "safety_class:C"

# Check verification completeness
tracertm report coverage \
  --from requirement \
  --to test_case \
  --threshold 100 \
  --fail-if-below-threshold
```

### Design and Development Validation (7.3.7)

Validation confirms the device meets user needs:

```markdown
## Validation Protocol: VP-001 Clinical Validation

**Objective**: Confirm device meets needs of intended users in representative use environment

**User Needs Validated**:
- UN-001: Ease of use for elderly patients
- UN-002: Accurate dosing in home environment
- UN-003: Clear alarm notifications
- UN-004: Battery life sufficient for daily use

**Methodology**:
- 30 patients with Type 1 diabetes
- 14-day home use study
- Questionnaires and observed use sessions
- Analysis of device logs

**Acceptance Criteria**:
- 95% of users can operate device without assistance
- Dosing accuracy within ±5% of prescribed dose
- 100% of users hear/see alarm notifications
- Battery lasts minimum 7 days

**Traceability**: All user needs linked to validation test results
```

### Design Transfer (7.3.8)

Document transfer from design to manufacturing:

```bash
# Link design outputs to manufacturing specs
tracertm link create DESIGN-OUTPUT-* --to-query "type:dmr_spec" --type transferred_to

# Verify manufacturing can reproduce design
tracertm item create "Design Transfer Report v1.0" --type transfer_report

# Production validation
tracertm item create "Process Validation Protocol" --type validation_protocol
```

### Design and Development Changes (7.3.9)

Manage design changes with impact analysis:

```bash
# Create change request
tracertm item create "CR-042: Update temperature alarm threshold" --type change_request

# Perform impact analysis
tracertm impact analyze SWR-002 --output impact-report-CR-042.md

# Review affected items
# - 3 downstream software requirements
# - 8 test cases
# - 2 design documents
# - 1 risk analysis

# Update risk analysis
tracertm link create CR-042 --to RA-UPDATE-v2.4 --type requires

# Approval workflow
tracertm item update CR-042 --status "Under Review"
tracertm item update CR-042 --reviewer "quality-team"
```

## Risk Management per ISO 14971

### Risk Management Process Integration

TraceRTM integrates risk management throughout the device lifecycle:

```bash
# Create risk management file
tracertm item create "Risk Management File - Device XYZ" --type risk_file

# Link to design plan
tracertm link create RISK-FILE-001 --to DESIGN-PLAN-001 --type supports
```

### Hazard Analysis

Document identified hazards and hazardous situations:

```markdown
## Hazard: HA-003 Patient Thermal Injury

**Hazardous Situation**: Device overheats during operation causing skin contact burn

**Harm**:
- Severity: Serious injury (first/second degree burn)
- Probability: Remote (< 1 in 100,000 uses)
- Risk Level: Medium

**Causes**:
- Power supply malfunction
- Cooling system failure
- Software error causing overheating
- Blocked ventilation

**Sequence of Events**:
1. Internal component temperature rises above safe limit
2. Protective mechanisms fail to activate
3. External surface temperature exceeds 43°C
4. Patient skin contact > 10 seconds
5. Thermal injury occurs

**Initial Risk Assessment**: Medium (Severity 3, Probability 2)
```

### Risk Control Measures

Link risk controls to requirements and verification:

```bash
# Create risk control measures
tracertm item create "Temperature Monitoring System" --type risk_control
tracertm item create "Automatic Shutdown on Overheat" --type risk_control
tracertm item create "Thermal Insulation Design" --type risk_control

# Link to hazards
tracertm link create RM-003 --to HA-003 --type mitigates

# Link to requirements
tracertm link create RM-003 --to SWR-001 --type implemented_by
tracertm link create RM-003 --to SWR-002 --type implemented_by
tracertm link create RM-003 --to SWR-003 --type implemented_by

# Link to verification
tracertm link create RM-003 --to TEST-042 --type verified_by
```

### Residual Risk Evaluation

After implementing controls, evaluate residual risk:

```markdown
## Residual Risk: HA-003 After Mitigation

**Risk Controls Implemented**:
- RM-003: Temperature monitoring with automatic alarm/shutdown
- RM-004: Thermal fuse backup protection
- RM-005: Insulated housing design
- RM-006: User manual warning about ventilation

**Residual Risk**:
- Severity: Serious injury (unchanged)
- Probability: Improbable (< 1 in 1,000,000 uses)
- Risk Level: Low

**Verification Status**: All controls verified (see test reports IT-042, IT-043, IT-044)

**Risk Acceptability**: ACCEPTABLE per risk acceptance criteria
- Risk level Low is acceptable for this severity
- Risk controls verified effective
- Benefits outweigh residual risk
- Approved by risk management committee 2024-12-06
```

### Risk Traceability Matrix

Generate comprehensive risk traceability:

```bash
# Risk traceability report
tracertm report matrix \
  --rows "type:hazard" \
  --cols "type:risk_control,requirement,test_case" \
  --output risk-traceability-matrix.xlsx

# Verify all hazards have controls
tracertm query "type:hazard AND NOT linked:risk_control" --expect-empty

# Verify all controls are verified
tracertm query "type:risk_control AND NOT linked:test_case" --expect-empty
```

## Design History File (DHF) Traceability

### DHF Contents

The Design History File contains all design and development records:

**Design Planning**:
- Design and development plan
- Resource allocation
- Review schedules

**Design Inputs**:
- User needs and requirements
- Regulatory requirements
- Standards requirements
- Risk management inputs

**Design Outputs**:
- Specifications (software, hardware, system)
- Drawings and schematics
- Bill of materials
- Manufacturing procedures

**Design Review**:
- Review meeting minutes
- Action items and resolutions
- Design approval records

**Design Verification**:
- Test plans and protocols
- Test reports and results
- Verification traceability matrix

**Design Validation**:
- Validation protocols
- Clinical evaluation reports
- User validation studies

**Design Transfer**:
- Transfer protocols
- Manufacturing procedures
- Production validation

**Design Changes**:
- Change requests
- Impact analyses
- Change approvals

### Generating DHF Packages

```bash
# Export complete DHF for a project
tracertm export dhf PROJECT-001 \
  --output dhf-insulin-pump-v2.0.zip \
  --include-audit-trail \
  --include-signatures \
  --format pdf

# Generate traceability matrices
tracertm report matrix \
  --rows "type:user_requirement" \
  --cols "type:design_spec,test_case,validation_result" \
  --output dhf/traceability-matrix.pdf

# Export by document type
tracertm export --filter "type:verification_report" --output dhf/verification/
tracertm export --filter "type:validation_report" --output dhf/validation/
tracertm export --filter "type:design_review" --output dhf/reviews/
```

### DHF Organization Best Practices

**Version Control**:
- Tag DHF snapshots at major milestones
- Maintain version history for all documents
- Use immutable storage for approved versions

**Indexing**:
- Maintain DHF index with document titles, versions, dates
- Cross-reference between related documents
- Include traceability matrices in DHF index

**Review and Approval**:
- Define signature authority matrix
- Require electronic signatures for critical documents
- Maintain approval records with audit trail

**Accessibility**:
- Organize DHF for easy retrieval during audits
- Provide table of contents with hyperlinks
- Include search functionality for large DHFs

## Verification and Validation Documentation

### Verification Testing Levels

**Unit Testing**:
```bash
# Track unit test coverage
tracertm report coverage \
  --from software_requirement \
  --to unit_test \
  --detail detailed

# Link unit test results
tracertm item update UNIT-TEST-042 \
  --status passed \
  --field test_date "2024-12-06" \
  --field tester "automation" \
  --field evidence "coverage-report-ut042.html"
```

**Integration Testing**:
```markdown
## Integration Test Report: IT-067

**Test Objective**: Verify alarm system integrates correctly with temperature monitoring

**Configuration**:
- Software version: 2.1.0-RC3
- Hardware: DevKit v3.2
- Test environment: Controlled chamber

**Test Results**:
- Pass: 24/25 test cases
- Fail: 1/25 test cases (IT-067-TC-015)
- Blocked: 0

**Failed Test Analysis**:
- TC-015: Alarm delay exceeded specification (2.3s vs 2.0s requirement)
- Root cause: Timer interrupt priority conflict
- Corrective action: Bug fix in ticket BUG-189
- Retest required: Yes

**Traceability**: Covers requirements SWR-001 through SWR-015
```

**System Testing**:
```bash
# System test execution tracking
tracertm item create "System Test Report v2.0" --type test_report

# Link to test cases
tracertm link create TEST-REPORT-001 --to-query "type:system_test_case" --type includes

# Track pass/fail status
tracertm item update SYS-TEST-001 --status passed
tracertm item update SYS-TEST-002 --status passed
tracertm item update SYS-TEST-003 --status failed --field defect "BUG-190"
```

### Validation Activities

**Clinical Validation**:
Document clinical evidence supporting safety and effectiveness:

```markdown
## Clinical Evaluation Report: CER-2024-001

**Device**: Continuous Glucose Monitor Model CGM-100
**Regulation**: FDA 510(k), ISO 13485

**Clinical Data Sources**:
1. Pivotal clinical study (n=120 patients, 14 days wear)
2. Literature review (15 peer-reviewed publications)
3. Post-market surveillance data (5,000+ device-years)

**Performance Endpoints**:
- Accuracy: Mean Absolute Relative Difference (MARD) < 10%
- Safety: Adverse events < 2% incidence
- Usability: Successful use without assistance > 95%

**Conclusions**:
- Device meets all performance requirements
- Safety profile acceptable for intended use
- Substantial equivalence to predicate device demonstrated

**Traceability**: Validates user needs UN-001 through UN-025
```

**Usability Validation**:
```bash
# Create usability validation protocol
tracertm item create "Usability Validation Protocol v1.0" --type validation_protocol

# Link to usability requirements
tracertm link create VAL-PROTO-001 --to-query "type:usability_requirement" --type validates

# Document validation results
tracertm item create "Usability Validation Report v1.0" --type validation_report
tracertm item update VAL-REPORT-001 --field participants "30 representative users"
tracertm item update VAL-REPORT-001 --field critical_tasks "15 tasks, 100% success rate"
tracertm item update VAL-REPORT-001 --field use_errors "2 minor errors, risk acceptable"
```

## Post-Market Surveillance Integration

### Complaint Handling

Link customer complaints to requirements and risk analysis:

```bash
# Create complaint record
tracertm item create "Complaint C-2024-1234" --type complaint
tracertm item update COMPLAINT-001 \
  --field description "Device alarm not heard by user" \
  --field severity "Moderate" \
  --field date_received "2024-12-01"

# Link to requirements
tracertm link create COMPLAINT-001 --to SWR-003 --type relates_to

# Link to risk analysis
tracertm link create COMPLAINT-001 --to HA-005 --type potential_hazard

# Investigation
tracertm item create "Investigation I-2024-567" --type investigation
tracertm link create INVESTIGATION-001 --to COMPLAINT-001 --type investigates

# Root cause
tracertm item update INVESTIGATION-001 \
  --field root_cause "Alarm volume insufficient in noisy environment" \
  --field corrective_action "Increase alarm volume, add vibration alert"

# Link to design change
tracertm link create INVESTIGATION-001 --to CR-098 --type results_in
```

### Field Actions and Recalls

Track field corrective actions:

```markdown
## Field Safety Corrective Action: FSCA-2024-003

**Type**: Voluntary recall - Class II
**Reason**: Software defect causing incorrect dose calculation in edge case
**Affected Products**: Serial numbers 10000-15000, Software v1.2.0-1.2.3
**Patient Impact**: Potential underdose in rare scenario (1 in 50,000 uses)

**Root Cause**: Integer overflow in dose calculation for maximum weight patients

**Corrective Action**:
- Software update to v1.2.4 addressing calculation error
- Customer notification letter sent 2024-11-15
- Field update completion target: 2024-12-31

**Traceability**:
- Affected requirement: SWR-089 (Dose calculation algorithm)
- Related test gap: Edge case for maximum weight not tested
- Risk analysis update: RA-UPDATE-v3.2

**Preventive Action**:
- Enhanced test coverage for boundary conditions
- Updated design review checklist
- Additional code review for arithmetic operations
```

### Periodic Safety Update Reports (PSUR)

```bash
# Generate PSUR data
tracertm report psur \
  --start-date 2024-01-01 \
  --end-date 2024-12-31 \
  --output psur-2024.pdf

# Include:
# - Devices sold/distributed
# - Complaints received
# - Adverse events
# - Field actions
# - Design changes
# - Risk analysis updates
```

## Real-World Medical Device Workflows

### Workflow 1: New Feature Development

```bash
# 1. Capture user need
tracertm item create "UN-042: Remote monitoring capability" --type user_need
tracertm item update UN-042 --field justification "Clinician request for patient monitoring"

# 2. Analyze regulatory impact
tracertm item create "REG-042: FDA guidance on mobile medical apps" --type regulatory_req
tracertm link create UN-042 --to REG-042 --type must_comply_with

# 3. Perform risk analysis
tracertm item create "HA-042: Unauthorized access to patient data" --type hazard
tracertm link create HA-042 --to UN-042 --type introduced_by

# 4. Define software requirements
tracertm item create "SWR-042: Encrypted communication channel" --type software_req
tracertm link create SWR-042 --to UN-042 --type derives_from
tracertm link create SWR-042 --to HA-042 --type mitigates

# 5. Design and implement
tracertm item create "DESIGN-042: TLS 1.3 implementation" --type design_spec
tracertm link create DESIGN-042 --to SWR-042 --type implements

# 6. Verify
tracertm item create "TEST-042: TLS security test suite" --type test_case
tracertm link create TEST-042 --to SWR-042 --type verifies

# 7. Update DHF
tracertm export dhf PROJECT-001 --version 2.1 --include-new-items
```

### Workflow 2: Responding to Field Complaint

```bash
# 1. Log complaint
tracertm item create "COMPLAINT-789: Battery drain faster than expected" --type complaint

# 2. Link to existing requirements
tracertm link create COMPLAINT-789 --to UN-015 --type relates_to  # Battery life requirement

# 3. Investigate
tracertm item create "INV-789: Battery life investigation" --type investigation
tracertm impact analyze UN-015 --output investigation-report.md

# 4. Identify affected components
# Impact analysis shows:
# - 2 battery-related requirements
# - 5 power management design specs
# - 12 related test cases
# - 1 risk control (power failure hazard)

# 5. Determine root cause
tracertm item update INV-789 --field root_cause "Bluetooth radio not entering sleep mode"

# 6. Create corrective action
tracertm item create "CR-120: Fix Bluetooth power management" --type change_request
tracertm link create CR-120 --to INV-789 --type addresses

# 7. Update risk analysis
tracertm item create "RA-UPDATE-v2.8: Power consumption risk re-evaluation" --type risk_analysis
tracertm link create RA-UPDATE-v2.8 --to CR-120 --type analyzes

# 8. Update verification tests
tracertm item update TEST-POWER-005 --field notes "Enhanced battery drain test per CR-120"
```

### Workflow 3: Regulatory Submission Preparation

```bash
# Generate 510(k) submission package
tracertm export regulatory \
  --type fda-510k \
  --project PROJECT-001 \
  --output 510k-submission/

# Included documents:
# - Device description
# - Indications for use
# - Substantial equivalence comparison
# - Software documentation (Level of Concern: Moderate)
# - Verification and validation summary
# - Risk analysis summary
# - Biocompatibility summary
# - Sterilization validation
# - Complete traceability matrices

# Generate software documentation per FDA guidance
tracertm report software-level-of-concern \
  --output sloc-assessment.pdf

tracertm export software-documentation \
  --level moderate \
  --output 510k-submission/software/

# Verify completeness
tracertm validate submission \
  --type fda-510k \
  --checklist fda-510k-checklist.yaml
```

## Best Practices for Regulated Medical Software

### 1. Requirements Management

**Write Verifiable Requirements**:
- Use quantitative acceptance criteria
- Avoid ambiguous terms (e.g., "fast", "reliable")
- Include units and tolerances
- Define pass/fail criteria

**Example - Poor**: "The system shall respond quickly"
**Example - Good**: "The system shall display results within 500ms ± 50ms of user input"

**Maintain Bidirectional Traceability**:
```bash
# Verify forward traceability (requirements to tests)
tracertm report coverage --from requirement --to test_case --threshold 100

# Verify backward traceability (tests to requirements)
tracertm query "type:test_case AND NOT linked:requirement" --expect-empty
```

**Use Clear Requirement Types**:
- User needs (stakeholder requirements)
- System requirements (high-level)
- Software requirements (derived)
- Hardware requirements
- Interface requirements

### 2. Version Control and Configuration Management

**Baseline Management**:
```bash
# Create baseline at milestone
tracertm baseline create "Release 2.0 Candidate" \
  --tag v2.0-RC1 \
  --freeze requirements

# Track changes after baseline
tracertm baseline compare v2.0-RC1 v2.0-RC2 --output changes-report.pdf
```

**Change Control**:
- Require approval for changes to baselined items
- Document rationale for all changes
- Perform impact analysis before approval
- Update affected test cases and documentation

### 3. Tool Validation

Per 21 CFR Part 11 and GAMP 5, validate TraceRTM as an electronic system:

```markdown
## Validation Protocol: TraceRTM Requirements Management System

**Validation Approach**: GAMP 5 Category 4 (Configurable software)

**Installation Qualification (IQ)**:
- Verify software version and integrity
- Confirm system requirements met
- Validate backup and disaster recovery
- Test user authentication and access controls

**Operational Qualification (OQ)**:
- Test all functional requirements
- Verify audit trail functionality
- Confirm electronic signature compliance
- Test traceability link creation and reporting

**Performance Qualification (PQ)**:
- Execute realistic medical device project
- Generate required regulatory reports
- Validate data integrity over time
- Confirm system performs in production environment

**Validation Report**: System validated for use in medical device development per 21 CFR Part 820.70(i)
```

### 4. Training and Competency

**Role-Based Training**:
- Requirements engineers: Requirement writing, traceability concepts
- Test engineers: Verification planning, test case creation
- Quality assurance: Audit trail review, compliance checking
- Regulatory affairs: Report generation, submission packages

**Competency Assessment**:
- Practical exercises creating requirements and links
- Quiz on regulatory requirements (FDA, ISO, IEC)
- Peer review of trainee work products

### 5. Continuous Compliance

**Periodic Audits**:
```bash
# Monthly compliance check
tracertm audit run \
  --check-orphan-requirements \
  --check-unverified-requirements \
  --check-missing-risk-controls \
  --output monthly-audit-2024-12.pdf
```

**Metrics and KPIs**:
- Requirements coverage: Target 100%
- Requirements stability: less than 10% change rate per month
- Test pass rate: greater than 95%
- Audit trail completeness: 100%
- Time to resolve defects: less than 30 days average

**Management Review**:
- Quarterly review of traceability metrics
- Review of post-market surveillance trending
- Assessment of process effectiveness
- Continuous improvement initiatives

---

## Additional Resources

**FDA Guidance Documents**:
- General Principles of Software Validation (2002)
- Cybersecurity in Medical Devices (2023)
- Design Control Guidance for Medical Device Manufacturers (1997)
- Off-The-Shelf Software Use in Medical Devices (1999)

**International Standards**:
- IEC 62304: Medical device software lifecycle processes
- ISO 13485: Quality management systems for medical devices
- ISO 14971: Application of risk management to medical devices
- IEC 62366: Usability engineering for medical devices

**TraceRTM Documentation**:
- [Getting Started Guide](/docs/getting-started)
- [API Reference](/api)
- [CLI Commands](/docs/cli)
- [Integration Guide](/docs/integration)

**Training Resources**:
- Medical Device Traceability Workshop (coming soon)
- FDA Compliance Video Series (coming soon)
- Example Medical Device Projects (coming soon)

---

*This document provides general guidance on medical device traceability practices. Organizations should consult with regulatory affairs professionals and legal counsel to ensure compliance with applicable regulations and standards for their specific devices and markets.*
