Gap Analysis Service

Perform comprehensive gap analysis on medical device Design History Files (DHF) against applicable regulatory standards.

Overview

The gap analysis service:

•Discovers existing documents in the project
•Compares against DCA requirements (or generates DCA if none exists)
•Identifies missing, incomplete, or outdated documentation
•Prioritizes gaps by regulatory severity
•Generates actionable gap reports

Usage

code

/gap-analysis <project-path>                    # Full gap analysis
/gap-analysis <project-path> --domain usability # Analyze specific domain
/gap-analysis <project-path> --quick            # Quick summary only
/gap-analysis <project-path> --report           # Generate formal report

Workflow

Phase 1: Document Discovery (Programmatic)

Scan project directory for DHF documents:

bash

# File patterns to discover
**/*.docx, **/*.odt, **/*.pdf, **/*.md

# Extract metadata from filenames
# Pattern: [prefix] DHFD-XX Title RXX ECRXXX (date).ext

Extract from each document:

•Document ID (DHFD-xx, QP-xx, QA-xx)
•Title
•Revision number
•ECR reference
•Date
•File path

Update registry: <project>/registry.json Schema: ~/Documents/DTGE/Work/workflow/schemas/registry.schema.json

Phase 2: DCA Verification

Check if DCA exists for project:

•If yes: Load <project>/dca.json
•If no: Prompt to run /dca first or generate basic DCA

Phase 3: Document Analysis (Hybrid)

For each document:

•

[Code] Extract text via LibreOffice MCP tools:

code

libreoffice/read_document_text
libreoffice/get_document_info

•
[Code] Parse document structure:
- •Section headings
- •Trace IDs (SYS-xxx, SRS-xxx, HZ-xx, SR-xx, C-xx)
- •Standard references
•
[LLM] Map to DCA requirements:
- •Which DCA items does this document address?
- •Is the coverage complete or partial?
- •Are there evidence gaps?

Phase 4: Gap Identification (LLM)

Compare DCA requirements against document registry:

Gap Types:

Type	Description	Example
`missing_document`	Required document doesn't exist	No Use Specification
`incomplete_coverage`	Document exists but doesn't fully address requirement	FMEA missing cybersecurity hazards
`outdated_reference`	Document references old standard version	ISO 14971:2007 instead of 2019
`evidence_gap`	Document exists but lacks required evidence	Missing summative evaluation data
`process_gap`	Required process not documented	No vulnerability management plan

Categorize by Domain:

•Usability (IEC 62366-1)
•Cybersecurity (FDA 2023 Guidance)
•Risk Management (ISO 14971)
•Software (IEC 62304)
•Hardware/Electrical Safety (IEC 60601-1)
•Labeling (IFU requirements)

Assign Severity:

Severity	Criteria
`critical`	Required for regulatory submission, no pathway without it
`high`	Strong expectation from FDA/notified body, may delay approval
`medium`	Expected documentation, strengthens submission
`low`	Best practice, nice to have

Phase 5: Output Generation (Hybrid)

Update gaps.json: <project>/gaps.json Schema: ~/Documents/DTGE/Work/workflow/schemas/gaps.schema.json

Generate Gap Report: Based on template from existing gap assessments

Gap Report Template

markdown

# Gap Assessment - {Project Name}

## 1. Purpose
Brief description of assessment scope and objectives.

## 2. Design Changes Under Assessment
If applicable, list ECRs and changes being evaluated.

## 3. Standards Evolution
Table of standards changes since predicate/last assessment.

## 4. Gap Assessment by Domain

### 4.1 Usability Engineering (IEC 62366-1)
#### Current State
#### Gap Analysis Table
| Requirement | Current Evidence | Gap Status | Priority |
#### Recommendations

### 4.2 Cybersecurity (FDA 2023 Guidance)
[Same structure]

### 4.3 Risk Management (ISO 14971:2019)
[Same structure]

### 4.4 Software Documentation (IEC 62304)
[Same structure]

### 4.5 Hardware Validation
[Same structure]

### 4.6 Labeling
[Same structure]

## 5. Summary and Prioritization

### 5.1 High Priority Gaps
| Gap ID | Domain | Description | Remediation |

### 5.2 Medium Priority Gaps
[Same table structure]

### 5.3 Lower Priority Gaps
[Same table structure]

## 6. Recommended Action Plan
Phased remediation approach.

## 7. Document References
| Document ID | Title | Relevance |

## 8. Revision History

Integration

From DCA

Gap analysis uses DCA as the "should have" baseline.

To Documentation Service

Gaps feed into /create-dhf for remediation document generation.

To Project Management

Gaps can trigger ECR creation via /ecr-manager.

Example Output

code

Gap Analysis Summary - Higi Green Special 510(k)

Documents Scanned: 47
DCA Requirements: 87

Coverage:
  Covered:    62 (71%)
  Partial:     8 (9%)
  Gap:        17 (20%)

Gaps by Severity:
  Critical:   4  (GAP-01, GAP-04, GAP-05, GAP-06)
  High:       5  (GAP-02, GAP-03, GAP-07, GAP-08, GAP-09)
  Medium:     6  (GAP-10 through GAP-15)
  Low:        2  (GAP-16, GAP-17)

Gaps by Domain:
  Usability:      4
  Cybersecurity:  4
  Risk Mgmt:      3
  Software:       4
  Hardware:       1
  Labeling:       1

Run `/gap-analysis --report` for full gap report.

Reference Documents

•Template: Work/Clients/Qualira/Higi/special_510k/11-Gap_Assessment/Special_510k_Gap_Assessment.md
•Existing traceability script: Work/Clients/Qualira/Higi/scripts/build_traceability_matrix.py