medical-device-mdr-auditor
Audit medical device technical files against EU MDR 2017/745 regulations.
Install via CLI (Recommended)
clawhub install openclaw/skills/skills/aipoch-ai/medical-device-mdr-auditorWhat This Skill Does
The medical-device-mdr-auditor is a specialized technical analysis tool designed to audit medical device technical documentation for compliance with the European Union Medical Device Regulation (EU MDR 2017/745). It functions as a structured compliance verification agent, mapping provided technical files against regulatory requirements to identify missing documentation, gaps in safety assessments, or non-conformities in clinical evaluation reports. By utilizing a reproducible, script-based execution model, this skill ensures that audits are consistent, objective, and auditable, significantly reducing the manual effort required to prepare documentation for Notified Body reviews.
Installation
To integrate this tool into your OpenClaw environment, ensure you have Python 3.10+ installed and the necessary dependencies defined in requirements.txt. Execute the following command from your terminal to install the skill package:
clawhub install openclaw/skills/skills/aipoch-ai/medical-device-mdr-auditor
After installation, verify the environment by running python -m py_compile scripts/main.py to ensure all paths are correctly configured and the code is parseable.
Use Cases
This skill is ideal for Quality Assurance (QA) and Regulatory Affairs (RA) professionals. Use it to perform internal pre-audits before submitting technical files for CE marking, conduct gap analyses on legacy technical files transitioning from MDD to MDR, or automate the verification of checklists during the development phase of a medical device. It is particularly effective for large documentation sets where manual checking is prone to oversight.
Example Prompts
- "Audit the technical file located at /data/device_files/ventilator_v2.pdf against the Annex II requirements of EU MDR 2017/745 and list any missing sections."
- "Perform a gap analysis on the current Clinical Evaluation Report and compare the results against the mandatory safety criteria in section 10.1 of the MDR."
- "Verify if the technical documentation for the implantable probe satisfies the Post-Market Surveillance (PMS) requirements specified in Article 83 of the regulation."
Tips & Limitations
The tool performs best when provided with well-structured files. It is not a legal advisor and should not be used as a final determination for market release; it serves as a decision-support aid. Always review the output for explicit assumptions made by the script during the audit process, as complex interpretations of regulatory clauses may require subject matter expert intervention.
Metadata
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Find the right skillPaste this into your clawhub.json to enable this plugin.
{
"plugins": {
"official-aipoch-ai-medical-device-mdr-auditor": {
"enabled": true,
"auto_update": true
}
}
}Tags(AI)
Flags: file-read, file-write, code-execution
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