🛠️ Mason: [Add Change Control Regulatory Impact Assessor]#582
🛠️ Mason: [Add Change Control Regulatory Impact Assessor]#582
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Pull request overview
Adds a new expert prompt under prompts/regulatory/quality to assess regulatory impact of medical device change controls across multiple jurisdictions, and wires it into the repository’s overview and docs navigation.
Changes:
- Introduces
change_control_regulatory_impact_assessor.prompt.yamlwith variables, structured XML-tagged output requirements, and basic evaluators. - Updates
prompts/regulatory/quality/overview.mdto list the new prompt. - Updates documentation indices (TOC + regulatory landing pages) and adds the generated prompt documentation page.
Reviewed changes
Copilot reviewed 6 out of 6 changed files in this pull request and generated 2 comments.
Show a summary per file
| File | Description |
|---|---|
| prompts/regulatory/quality/overview.md | Adds the new prompt to the quality overview list. |
| prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.yaml | New change-control regulatory impact assessor prompt definition. |
| docs/table-of-contents.md | Adds the new prompt doc page to the global docs TOC. |
| docs/regulatory.md | Adds the new prompt link to the regulatory docs index. |
| docs/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.md | Adds the generated documentation page for the new prompt. |
| docs/index.md | Adds the new prompt link to the docs homepage prompt listing. |
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| Target Jurisdictions: {{jurisdictions}} | ||
| </input> | ||
| testData: | ||
| - input: |
| testData: | ||
| - input: | ||
| device_description: "Class II (US) / Class IIb (EU) electro-surgical generator intended for cutting and coagulating tissue." | ||
| proposed_change: "Change in the main microcontroller unit (MCU) due to component obsolescence. The new MCU has the same core architecture but operates at a higher clock speed. Software requires a minor update to adjust timing loops, but no changes to the algorithm, GUI, or safety features." | ||
| jurisdictions: "US FDA, EU MDR" | ||
| expected: "1. Executive Summary" |
💡 What
Added a new expert-level prompt
change_control_regulatory_impact_assessor.prompt.yamlwithin theprompts/regulatory/qualitydomain. It acts as a Principal Regulatory Affairs Change Control Architect to evaluate proposed medical device changes against jurisdictional frameworks (e.g., US FDA, EU MDR).🎯 Why
Gap Analysis identified a critical void in the
regulatory/qualityecosystem. While CAPA, complaints, and FDA 483 responses were addressed, there was no prompt dedicated to the rigorous, multi-jurisdictional regulatory impact assessment of proposed changes to marketed devices (a ubiquitous and high-risk task in QMS).📊 Impact
Provides Quality and Regulatory professionals with a highly analytical, objective tool to explicitly determine if a change is 'Significant' (requiring submission) or 'Non-Significant' (requiring only a Letter to File), standardizing documentation and mitigating compliance risks.
PR created automatically by Jules for task 17459061468396427450 started by @fderuiter