Medical Device MDR Auditor

---

name: medical-device-mdr-auditor

description: Audit medical device technical files against EU MDR 2017/745 regulations.

license: MIT

skill-author: AIPOCH

---

# Medical Device MDR Auditor

**ID**: 130

**Version**: 1.0.0

**Description**: Check whether medical device technical files contain required documents according to EU MDR (2017/745) regulations

---

When to Use

Key Features

Dependencies

See `## Prerequisites` above for related details.

Example Usage

See `## Usage` above for related details.

cd "20260318/scientific-skills/Academic Writing/medical-device-mdr-auditor"
python -m py_compile scripts/main.py
python scripts/main.py --help

Example run plan:

1. Confirm the user input, output path, and any required config values.

2. Edit the in-file `CONFIG` block or documented parameters if the script uses fixed settings.

3. Run `python scripts/main.py` with the validated inputs.

4. Review the generated output and return the final artifact with any assumptions called out.

Implementation Details

See `## Workflow` above for related details.

Quick Check

Use this command to verify that the packaged script entry point can be parsed before deeper execution.

python -m py_compile scripts/main.py

Audit-Ready Commands

Use these concrete commands for validation. They are intentionally self-contained and avoid placeholder paths.

python -m py_compile scripts/main.py
python scripts/main.py --help
python scripts/main.py -h

Workflow

1. Confirm the user objective, required inputs, and non-negotiable constraints before doing detailed work.

2. Validate that the request matches the documented scope and stop early if the task would require unsupported assumptions.

3. Use the packaged script path or the documented reasoning path with only the inputs that are actually available.

4. Return a structured result that separates assumptions, deliverables, risks, and unresolved items.

5. If execution fails or inputs are incomplete, switch to the fallback path and state exactly what blocked full completion.

Overview

This Skill is used to audit the compliance of medical device technical files, checking whether documents contain necessary Clinical Evaluation Reports and Post-Market Surveillance plans according to EU MDR 2017/745 regulatory requirements.

Usage

# Check single technical file directory
python3 /Users/z04030865/.openclaw/workspace/skills/medical-device-mdr-auditor/scripts/main.py --input /path/to/technical/file --class IIa

# Batch check using JSON configuration file
python3 /Users/z04030865/.openclaw/workspace/skills/medical-device-mdr-auditor/scripts/main.py --config /path/to/config.json

# Output detailed report
python3 /Users/z04030865/.openclaw/workspace/skills/medical-device-mdr-auditor/scripts/main.py --input /path/to/technical/file --class III --verbose --output report.json

Parameters

| Parameter | Type | Required | Description |

|-----------|------|----------|-------------|

| `--input` | string | Conditional | Technical file directory path |

| `--config` | string | Conditional | JSON configuration file path |

| `--class` | string | Yes | Device classification (I, IIa, IIb, III) |

| `--output` | string | No | Output report path |

| `--verbose` | flag | No | Output detailed information |

MDR 2017/745 Check Points

1. Clinical Evaluation Report (CER)

According to MDR Annex XIV Part A, must include:

2. Post-Market Surveillance Plan (PMS)

According to MDR Article 83 & Annex III, must include:

3. Post-Market Clinical Follow-up Plan (PMCF Plan)

According to MDR Annex XIV Part B, for Class IIa and above devices:

4. Other Key Documents

Output Format

Compliance Report Example

{
  "audit_date": "2026-02-06T06:00:00Z",
  "device_class": "IIa",
  "compliance_status": "PARTIAL",
  "findings": [
    {
      "category": "CRITICAL",
      "regulation": "MDR Annex XIV Part A",
      "item": "Clinical Evaluation Report",
      "status": "MISSING",
      "description": "Clinical evaluation report file not found"
    },
    {
      "category": "MAJOR",
      "regulation": "MDR Article 83",
      "item": "PMS Plan",
      "status": "INCOMPLETE",
      "description": "PMS plan lacks trend reporting mechanism"
    }
  ],
  "summary": {
    "total_checks": 12,
    "passed": 8,
    "warnings": 2,
    "failed": 2
  }
}

Compliance Levels

| Level | Description |

|-------|-------------|

| `COMPLIANT` | Fully compliant with MDR requirements |

| `PARTIAL` | Partially compliant, with correctable deficiencies |

| `NON_COMPLIANT` | Seriously non-compliant, critical documents missing |

Exit Codes

| Code | Meaning |

|------|---------|

| 0 | Audit passed, fully compliant |

| 1 | Audit passed, with warnings |

| 2 | Audit failed, with deficiencies |

| 3 | Execution error |

References

Author

OpenClaw Skill Development Team

Risk Assessment

| Risk Indicator | Assessment | Level |

|----------------|------------|-------|

| Code Execution | Python/R scripts executed locally | Medium |

| Network Access | No external API calls | Low |

| File System Access | Read input files, write output files | Medium |

| Instruction Tampering | Standard prompt guidelines | Low |

| Data Exposure | Output files saved to workspace | Low |

Security Checklist

Prerequisites

# Python dependencies
pip install -r requirements.txt

Evaluation Criteria

Success Metrics

Test Cases

1. **Basic Functionality**: Standard input → Expected output

2. **Edge Case**: Invalid input → Graceful error handling

3. **Performance**: Large dataset → Acceptable processing time

Lifecycle Status

- Performance optimization

- Additional feature support

Output Requirements

Every final response should make these items explicit when they are relevant:

Error Handling

Input Validation

This skill accepts requests that match the documented purpose of `medical-device-mdr-auditor` and include enough context to complete the workflow safely.

Do not continue the workflow when the request is out of scope, missing a critical input, or would require unsupported assumptions. Instead respond:

> `medical-device-mdr-auditor` only handles its documented workflow. Please provide the missing required inputs or switch to a more suitable skill.

References

Response Template

Use the following fixed structure for non-trivial requests:

1. Objective

2. Inputs Received

3. Assumptions

4. Workflow

5. Deliverable

6. Risks and Limits

7. Next Checks

If the request is simple, you may compress the structure, but still keep assumptions and limits explicit when they affect correctness.