From 8ce3d651876814ff3630f1c0be3d5d77191fa2df Mon Sep 17 00:00:00 2001
From: fderuiter <127706008+fderuiter@users.noreply.github.com>
Date: Sun, 15 Mar 2026 19:44:14 +0000
Subject: [PATCH 1/2] feat(regulatory): add Change Control Regulatory Impact
 Assessor prompt

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 | 77 +++++++++++++++++++
 docs/regulatory.md                            |  1 +
 docs/table-of-contents.md                     |  1 +
 ...rol_regulatory_impact_assessor.prompt.yaml | 64 +++++++++++++++
 5 files changed, 144 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..e798443b
--- /dev/null
+++ b/docs/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.md
@@ -0,0 +1,77 @@
+---
+title: Change Control Regulatory Impact Assessor
+---
+
+# Change Control Regulatory Impact Assessor
+
+Perform rigorous regulatory impact assessments for proposed medical device changes using FDA guidance.
+
+[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: Perform rigorous regulatory impact assessments for proposed medical device changes using FDA guidance.
+authors:
+  - "Strategic Genesis Architect"
+metadata:
+  domain: regulatory
+  complexity: high
+  tags:
+    - quality
+    - change-control
+    - fda
+    - regulatory-impact
+    - "510k"
+  requires_context: false
+variables:
+  - name: proposed_change_description
+    description: Detailed description of the proposed change to the medical device.
+    required: true
+  - name: device_classification
+    description: FDA classification of the device (e.g., Class II).
+    required: true
+  - name: current_clearance_basis
+    description: Basis of current clearance or approval (e.g., 510(k), PMA).
+    required: true
+model: gpt-4o
+modelParameters:
+  temperature: 0.1
+messages:
+  - role: system
+    content: >
+      Act as a Principal QMS Change Control Architect and Regulatory Affairs Specialist to perform rigorous regulatory impact assessments for proposed medical device changes using FDA guidance.
+
+      Your analysis must:
+      1. Determine if the proposed change could significantly affect the safety or effectiveness of the device.
+      2. Evaluate if the change represents a major change or modification in the intended use.
+      3. Recommend whether a new 510(k) or PMA supplement is required based on FDA's "Deciding When to Submit a 510(k) for a Change to an Existing Device" guidance.
+      4. Detail the documentation required for the 'Letter to File' if a new submission is not required.
+
+      Enforce strict compliance with 21 CFR Part 820.30(i) Design Changes and 820.70(b) Production and Process Changes. Produce a structured, authoritative assessment report.
+  - role: user
+    content: >
+      Please evaluate the regulatory impact of the following change:
+
+      <proposed_change_description>{{proposed_change_description}}</proposed_change_description>
+      <device_classification>{{device_classification}}</device_classification>
+      <current_clearance_basis>{{current_clearance_basis}}</current_clearance_basis>
+testData:
+  - input:
+      proposed_change_description: "Changing the housing material of the device from Polycarbonate to a new proprietary ABS blend to reduce manufacturing costs. The new material has not been previously used in our cleared devices."
+      device_classification: "Class II"
+      current_clearance_basis: "510(k)"
+    expected: "biocompatibility"
+evaluators:
+  - name: Safety and Effectiveness Check
+    regex:
+      pattern: (?i)safety\s+or\s+effectiveness
+  - name: FDA Guidance Reference
+    regex:
+      pattern: (?i)Deciding\s+When\s+to\s+Submit
+  - name: Recommendation Check
+    regex:
+      pattern: (?i)(510\(k\)|Letter\s+to\s+File)
+
+```
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..8c4c569a
--- /dev/null
+++ b/prompts/regulatory/quality/change_control_regulatory_impact_assessor.prompt.yaml
@@ -0,0 +1,64 @@
+---
+name: Change Control Regulatory Impact Assessor
+version: 1.0.0
+description: Perform rigorous regulatory impact assessments for proposed medical device changes using FDA guidance.
+authors:
+  - "Strategic Genesis Architect"
+metadata:
+  domain: regulatory
+  complexity: high
+  tags:
+    - quality
+    - change-control
+    - fda
+    - regulatory-impact
+    - "510k"
+  requires_context: false
+variables:
+  - name: proposed_change_description
+    description: Detailed description of the proposed change to the medical device.
+    required: true
+  - name: device_classification
+    description: FDA classification of the device (e.g., Class II).
+    required: true
+  - name: current_clearance_basis
+    description: Basis of current clearance or approval (e.g., 510(k), PMA).
+    required: true
+model: gpt-4o
+modelParameters:
+  temperature: 0.1
+messages:
+  - role: system
+    content: >
+      Act as a Principal QMS Change Control Architect and Regulatory Affairs Specialist to perform rigorous regulatory impact assessments for proposed medical device changes using FDA guidance.
+
+      Your analysis must:
+      1. Determine if the proposed change could significantly affect the safety or effectiveness of the device.
+      2. Evaluate if the change represents a major change or modification in the intended use.
+      3. Recommend whether a new 510(k) or PMA supplement is required based on FDA's "Deciding When to Submit a 510(k) for a Change to an Existing Device" guidance.
+      4. Detail the documentation required for the 'Letter to File' if a new submission is not required.
+
+      Enforce strict compliance with 21 CFR Part 820.30(i) Design Changes and 820.70(b) Production and Process Changes. Produce a structured, authoritative assessment report.
+  - role: user
+    content: >
+      Please evaluate the regulatory impact of the following change:
+
+      <proposed_change_description>{{proposed_change_description}}</proposed_change_description>
+      <device_classification>{{device_classification}}</device_classification>
+      <current_clearance_basis>{{current_clearance_basis}}</current_clearance_basis>
+testData:
+  - input:
+      proposed_change_description: "Changing the housing material of the device from Polycarbonate to a new proprietary ABS blend to reduce manufacturing costs. The new material has not been previously used in our cleared devices."
+      device_classification: "Class II"
+      current_clearance_basis: "510(k)"
+    expected: "biocompatibility"
+evaluators:
+  - name: Safety and Effectiveness Check
+    regex:
+      pattern: (?i)safety\s+or\s+effectiveness
+  - name: FDA Guidance Reference
+    regex:
+      pattern: (?i)Deciding\s+When\s+to\s+Submit
+  - name: Recommendation Check
+    regex:
+      pattern: (?i)(510\(k\)|Letter\s+to\s+File)

From cf46d693b85b416056b48b3b2e67b6b6b858ca50 Mon Sep 17 00:00:00 2001
From: github-actions <github-actions@github.com>
Date: Sun, 15 Mar 2026 19:44:45 +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..97029361 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)**: Perform rigorous regulatory impact assessments for proposed medical device changes using FDA guidance.
 - **[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.