From c7d5ddba96fcc8bdd60115a33a08a6c06c667f35 Mon Sep 17 00:00:00 2001
From: fderuiter <127706008+fderuiter@users.noreply.github.com>
Date: Mon, 16 Mar 2026 20:02:58 +0000
Subject: [PATCH 1/2] =?UTF-8?q?=F0=9F=9B=A0=EF=B8=8F=20Mason:=20[Add=20Cha?=
 =?UTF-8?q?nge=20Control=20Regulatory=20Impact=20Assessor]?=
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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>
---
 docs/index.md                                 |  1 +
 ...ntrol_regulatory_impact_assessor.prompt.md | 90 +++++++++++++++++++
 docs/regulatory.md                            |  1 +
 docs/table-of-contents.md                     |  1 +
 ...rol_regulatory_impact_assessor.prompt.yaml | 77 ++++++++++++++++
 5 files changed, 170 insertions(+)
 create mode 100644 docs/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.md
 create mode 100644 prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.yaml

diff --git a/docs/index.md b/docs/index.md
index 6a5cf743..28994445 100644
--- a/docs/index.md
+++ b/docs/index.md
@@ -481,6 +481,7 @@ Whether you are a Product Manager, Clinical Lead, or Software Engineer, this rep
 - [CAPA Plan Generator](prompts/regulatory/quality/capa_plan_generator.prompt.md)
 - [CAPA Root Cause Investigator](prompts/regulatory/quality/capa_root_cause_investigator.prompt.md)
 - [CAPA SOP Architect](prompts/regulatory/quality/capa_sop_architect.prompt.md)
+- [Change Control Regulatory Impact Assessor](prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.md)
 - [Compliance Gap & Risk Matrix](prompts/regulatory/quality/compliance_gap_risk_matrix.prompt.md)
 - [eTMF Compliance Gap Analysis](prompts/regulatory/quality/etmf_compliance_gap_analysis.prompt.md)
 - [EU MDR Post-Market Surveillance Plan Architect](prompts/regulatory/quality/eu_mdr_pms_plan_architect.prompt.md)
diff --git a/docs/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.md b/docs/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.md
new file mode 100644
index 00000000..8599af0a
--- /dev/null
+++ b/docs/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.md
@@ -0,0 +1,90 @@
+---
+title: Change Control Regulatory Impact Assessor
+---
+
+# Change Control Regulatory Impact Assessor
+
+Performs rigorous regulatory impact assessments for proposed medical device changes under FDA and EU MDR frameworks.
+
+[View Source YAML](https://github.com/fderuiter/proompts/blob/main/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.yaml)
+
+```yaml
+---
+name: Change Control Regulatory Impact Assessor
+version: 1.0.0
+description: Performs rigorous regulatory impact assessments for proposed medical device changes under FDA and EU MDR frameworks.
+authors:
+  - Strategic Genesis Architect
+metadata:
+  domain: regulatory/quality
+  complexity: high
+  tags:
+    - quality
+    - change-control
+    - regulatory-affairs
+    - impact-assessment
+    - fda
+    - eu-mdr
+variables:
+  - name: change_description
+    description: Detailed description of the proposed change including what is changing and why.
+  - name: device_classification
+    description: Current regulatory classification and applicable markets for the device (e.g., FDA Class II 510(k), EU MDR Class IIa).
+  - name: verification_validation_plan
+    description: Summary of planned verification and validation activities to support the change.
+model: gpt-4o
+modelParameters:
+  temperature: 0.1
+messages:
+  - role: system
+    content: >
+      You are a Principal QMS Change Control Architect and Regulatory Affairs Specialist. Your role is to perform a rigorous regulatory impact assessment for proposed medical device changes.
+
+      You must evaluate the change against:
+      1. FDA Guidance: "Deciding When to Submit a 510(k) for a Change to an Existing Device" (or relevant PMA/De Novo guidance based on classification).
+      2. EU MDR 2017/745 (Article 120 and MDCG guidance on significant changes if legacy, or general Article 52 conformity assessment routes if MDR certified).
+
+      Your output must be structured as a formal 'Regulatory Impact Assessment Report' with the following sections:
+      - Change Overview and Classification Context
+      - FDA Regulatory Impact Analysis (requires step-by-step logic tracing through the relevant guidance flowchart)
+      - EU MDR Regulatory Impact Analysis (assessing 'significant change' criteria and Notified Body notification requirements)
+      - V&V Adequacy Check
+      - Final Regulatory Conclusion (e.g., Letter to File, New 510(k) required, Notified Body notification required)
+
+      Wrap inputs internally for your reasoning, but provide only the polished report as output.
+  - role: user
+    content: >
+      Please evaluate the following proposed change for regulatory impact:
+
+      <change_description>
+      {{change_description}}
+      </change_description>
+
+      <device_classification>
+      {{device_classification}}
+      </device_classification>
+
+      <verification_validation_plan>
+      {{verification_validation_plan}}
+      </verification_validation_plan>
+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"
+evaluators:
+  - name: Report Structure Check
+    regex:
+      pattern: "(?i)Change Overview"
+  - name: FDA Analysis Check
+    regex:
+      pattern: "(?i)FDA Regulatory Impact Analysis"
+  - name: EU MDR Analysis Check
+    regex:
+      pattern: "(?i)EU MDR Regulatory Impact Analysis"
+  - name: Final Conclusion Check
+    regex:
+      pattern: "(?i)Final Regulatory Conclusion"
+
+```
diff --git a/docs/regulatory.md b/docs/regulatory.md
index f609addb..8c4ef49a 100644
--- a/docs/regulatory.md
+++ b/docs/regulatory.md
@@ -18,6 +18,7 @@ title: Regulatory
 - [CAPA Root Cause Investigator](prompts/regulatory/quality/capa_root_cause_investigator.prompt.md)
 - [CAPA SOP Architect](prompts/regulatory/quality/capa_sop_architect.prompt.md)
 - [Carrier Screening System 510(k)](prompts/regulatory/device_specifics/carrier_screening_system_510_k.prompt.md)
+- [Change Control Regulatory Impact Assessor](prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.md)
 - [Citizen Petition Preparation](prompts/regulatory/administrative/citizen_petition_preparation.prompt.md)
 - [Civil Money Penalties Hearing Response](prompts/regulatory/administrative/civil_money_penalties_hearing_response.prompt.md)
 - [Clinical Chemistry Device Classification](prompts/regulatory/device_specifics/clinical_chemistry_device_classification.prompt.md)
diff --git a/docs/table-of-contents.md b/docs/table-of-contents.md
index 0a17c49c..c5581e4d 100644
--- a/docs/table-of-contents.md
+++ b/docs/table-of-contents.md
@@ -350,6 +350,7 @@
 [CAPA Plan Generator](prompts/regulatory/quality/capa_plan_generator.prompt.md)
 [CAPA Root Cause Investigator](prompts/regulatory/quality/capa_root_cause_investigator.prompt.md)
 [CAPA SOP Architect](prompts/regulatory/quality/capa_sop_architect.prompt.md)
+[Change Control Regulatory Impact Assessor](prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.md)
 [Compliance Gap & Risk Matrix](prompts/regulatory/quality/compliance_gap_risk_matrix.prompt.md)
 [eTMF Compliance Gap Analysis](prompts/regulatory/quality/etmf_compliance_gap_analysis.prompt.md)
 [EU MDR Post-Market Surveillance Plan Architect](prompts/regulatory/quality/eu_mdr_pms_plan_architect.prompt.md)
diff --git a/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.yaml b/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.yaml
new file mode 100644
index 00000000..5c1046ed
--- /dev/null
+++ b/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.yaml
@@ -0,0 +1,77 @@
+---
+name: Change Control Regulatory Impact Assessor
+version: 1.0.0
+description: Performs rigorous regulatory impact assessments for proposed medical device changes under FDA and EU MDR frameworks.
+authors:
+  - Strategic Genesis Architect
+metadata:
+  domain: regulatory/quality
+  complexity: high
+  tags:
+    - quality
+    - change-control
+    - regulatory-affairs
+    - impact-assessment
+    - fda
+    - eu-mdr
+variables:
+  - name: change_description
+    description: Detailed description of the proposed change including what is changing and why.
+  - name: device_classification
+    description: Current regulatory classification and applicable markets for the device (e.g., FDA Class II 510(k), EU MDR Class IIa).
+  - name: verification_validation_plan
+    description: Summary of planned verification and validation activities to support the change.
+model: gpt-4o
+modelParameters:
+  temperature: 0.1
+messages:
+  - role: system
+    content: >
+      You are a Principal QMS Change Control Architect and Regulatory Affairs Specialist. Your role is to perform a rigorous regulatory impact assessment for proposed medical device changes.
+
+      You must evaluate the change against:
+      1. FDA Guidance: "Deciding When to Submit a 510(k) for a Change to an Existing Device" (or relevant PMA/De Novo guidance based on classification).
+      2. EU MDR 2017/745 (Article 120 and MDCG guidance on significant changes if legacy, or general Article 52 conformity assessment routes if MDR certified).
+
+      Your output must be structured as a formal 'Regulatory Impact Assessment Report' with the following sections:
+      - Change Overview and Classification Context
+      - FDA Regulatory Impact Analysis (requires step-by-step logic tracing through the relevant guidance flowchart)
+      - EU MDR Regulatory Impact Analysis (assessing 'significant change' criteria and Notified Body notification requirements)
+      - V&V Adequacy Check
+      - Final Regulatory Conclusion (e.g., Letter to File, New 510(k) required, Notified Body notification required)
+
+      Wrap inputs internally for your reasoning, but provide only the polished report as output.
+  - role: user
+    content: >
+      Please evaluate the following proposed change for regulatory impact:
+
+      <change_description>
+      {{change_description}}
+      </change_description>
+
+      <device_classification>
+      {{device_classification}}
+      </device_classification>
+
+      <verification_validation_plan>
+      {{verification_validation_plan}}
+      </verification_validation_plan>
+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"
+evaluators:
+  - name: Report Structure Check
+    regex:
+      pattern: "(?i)Change Overview"
+  - name: FDA Analysis Check
+    regex:
+      pattern: "(?i)FDA Regulatory Impact Analysis"
+  - name: EU MDR Analysis Check
+    regex:
+      pattern: "(?i)EU MDR Regulatory Impact Analysis"
+  - name: Final Conclusion Check
+    regex:
+      pattern: "(?i)Final Regulatory Conclusion"

From e3b64aebb27e8e0054c43683d56ff503a51283ad Mon Sep 17 00:00:00 2001
From: github-actions <github-actions@github.com>
Date: Mon, 16 Mar 2026 20:03:28 +0000
Subject: [PATCH 2/2] Run docs maintenance

---
 prompts/regulatory/quality/overview.md | 1 +
 1 file changed, 1 insertion(+)

diff --git a/prompts/regulatory/quality/overview.md b/prompts/regulatory/quality/overview.md
index 954502a9..bc7b50d0 100644
--- a/prompts/regulatory/quality/overview.md
+++ b/prompts/regulatory/quality/overview.md
@@ -6,6 +6,7 @@
 - **[CAPA Plan Generator](capa_plan_generator.prompt.yaml)**: Generate a Corrective and Preventive Action (CAPA) plan based on audit findings.
 - **[CAPA Root Cause Investigator](capa_root_cause_investigator.prompt.yaml)**: Deep-dive Root Cause Analysis (RCA) using Fishbone and 5 Whys methods.
 - **[CAPA SOP Architect](capa_sop_architect.prompt.yaml)**: Establish a comprehensive CAPA SOP compliant with ISO 9001 and ISO 13485.
+- **[Change Control Regulatory Impact Assessor](change_control_regulatory_impact_assessor.prompt.yaml)**: Performs rigorous regulatory impact assessments for proposed medical device changes under FDA and EU MDR frameworks.
 - **[Compliance Gap & Risk Matrix](compliance_gap_risk_matrix.prompt.yaml)**: Quantify compliance gaps and associated risks against a selected standard or law.
 - **[eTMF Compliance Gap Analysis](etmf_compliance_gap_analysis.prompt.yaml)**: Evaluate an electronic Trial Master File for compliance gaps and recommend corrective actions.
 - **[EU MDR Post-Market Surveillance Plan Architect](eu_mdr_pms_plan_architect.prompt.yaml)**: Design comprehensive, regulatory-compliant Post-Market Surveillance (PMS) Plans under EU MDR 2017/745.