Add Change Control Regulatory Impact Assessor prompt#593
Add Change Control Regulatory Impact Assessor prompt#593
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💡 What: Added a new prompt template for a "Change Control Regulatory Impact Assessor". Updated documentation indices. 🎯 Why: This prompt fills a critical gap in the regulatory/quality domain by providing an expert-level, highly specific tool for performing regulatory impact assessments for proposed medical device changes under FDA and EU MDR frameworks. 📊 Impact: Expands the regulatory/quality prompt repository with a high-value workflow for Quality Management Systems. Co-authored-by: google-labs-jules[bot] <161369871+google-labs-jules[bot]@users.noreply.github.com>
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Pull request overview
Adds a new regulatory/quality prompt for performing change-control regulatory impact assessments (FDA 510(k) change guidance + EU MDR) and updates the documentation indices so the new prompt appears in site navigation.
Changes:
- Added
Change Control Regulatory Impact Assessorprompt YAML underprompts/regulatory/quality/. - Generated corresponding rendered docs page for the new prompt.
- Updated domain overview and global docs indices to include the new prompt.
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 regulatory/quality overview list. |
| prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.yaml | Introduces the new change-control regulatory impact assessor prompt definition. |
| docs/table-of-contents.md | Adds the new prompt page to the docs TOC. |
| docs/regulatory.md | Adds the new prompt page to the regulatory docs index. |
| docs/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.md | Adds the rendered documentation page for the new prompt. |
| docs/index.md | Adds the new prompt page to the main docs index list. |
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| {{verification_validation_plan}} | ||
| </verification_validation_plan> | ||
| testData: | ||
| - input: |
| testData: | ||
| - input: | ||
| change_description: "Replacing the current polycarbonate (PC) housing material with a new ABS plastic blend due to supply chain issues. The housing is non-patient-contacting but provides structural support for internal electronics." | ||
| device_classification: "FDA Class II (cleared under a 510(k)), EU MDR Class IIa (MDR CE marked)." | ||
| verification_validation_plan: "Drop testing, IP54 ingress protection testing, and structural integrity testing will be performed. No clinical or biocompatibility testing is planned as the component is externally facing and non-patient contacting." | ||
| expected: "FDA Regulatory Impact Analysis" |
Adds the
change_control_regulatory_impact_assessor.prompt.yamlto theregulatory/qualitydomain, acting as a Principal QMS Change Control Architect and Regulatory Affairs Specialist. Also updates corresponding documentation indices.PR created automatically by Jules for task 15813815050254233428 started by @fderuiter