GSTT-CSC · ElisePather · Nov 11, 2025
diff --git a/documentation/data/device.yml b/documentation/data/device.yml
@@ -13,7 +13,7 @@ version: "v0.1.0"
 # "A" - No injury or damage to health is possible
 # "B" - Non-serious injury is possible
 # "C" - Death or serious injury is possible
-safety_class: B
+BS62304_class: B
 
 # The MHRA medical device classification for this applications
 # "I" -

diff --git a/documentation/data/requirements.yml b/documentation/data/requirements.yml
@@ -3,30 +3,34 @@ requirements:
     title: First Example Requirement
     type: Input/Output
     description: A brief description of the requirement; should use the world "shall".
-    specifications: |
+    priority: v1
   - id: r-2
     title: Second Example Requirement
     type: Functional
     description: Requirements describe what the software needs to do, and not how.
+    priority: v1
   - id: r-3-1
     title: Third Example Requirement Nested Id First Item
     type: Functional
     description: Requirements should be verifiable (e.g., testable).
+    priority: v1
   - id: r-3-2
     title: Fourth Example Requirement Nested Id Second Item
     type: Functional
     description: Requirements can be written using markdown.
+    priority: v1
+
+sys_des_spec:
+  - id: SDS_001
+    priority: v1.0.0
+    title: Example design specification
+    type: Example design specification type
+    description: Example design specification description
+    linked_reqs: SRS-001
+  - id: SDS_002
+    priority: v1.0.0
+    title: Example design specification
+    type: Example design specification type
+    description: Example design specification description
+    linked_reqs: SRS-002
 
-specification:
-  - id: sr-1
-    title: some title
-    req_id: r-1
-    description: Adds some descirptino to the specification
-  - id: sr-2
-    title: some title
-    req_id: r-1
-    description: Adds some descirptino to the specification
-  - id: sr-3
-    title: some title
-    req_id: r-1
-    description: Adds some descirptino to the specification
diff --git a/documentation/data/risk.yml b/documentation/data/risk.yml
@@ -34,20 +34,15 @@ risk_acceptability_matrix:
     - [Low, Low, Medium, Medium, High]
     - [Low, Medium, Medium, High, High]
 risks:
-    - id: hz-1
-      hazard: Incorrect information
-      software_item: Annotation Metric Calculator
-      events: |
-          - A software defect in the Annotation Metric Calculator causes the
-            size an annotated tumor to be significantly under-estimated
-          - The radiologist fails to notice the discrepancy
-      hazardous_situation: The oncologist is presented with incorrect tumor sizes
-      harm: An inappropriate therapy is given to the patient
-      severity: Catastrophic
-      probability: Low
-      control_measures: null
-      residual_severity: null
-      residual_probability: null
-      notes: Although it is not possible to estimate the probability of the
-          software defect occurring, it is unlikely that the radiologist would not
-          noticed the discrepancy.
+    - hazard_id: HZ-001-01
+      hazard: Delays in treatment
+      causes: AIDE unavailable for technical reasons
+      effects: Delays in contouring and planning
+      harm: Patient distress and tumour progression
+      severity: Moderate
+      likelihood: 2
+      risk: 2
+      risk_control: Revert to manual contouring
+      residual_likelihood: 1
+      residual_risk: 1
+      comment:
diff --git a/documentation/documents/.DS_Store b/documentation/documents/.DS_Store
diff --git a/documentation/documents/acceptance_criteria.md b/documentation/documents/acceptance_criteria.md
@@ -0,0 +1,70 @@
+---
+qms_version: 2.2.0
+sop_id: CSC PR.012
+sop_version: 
+template_id: CSC F.030
+template_version: 2.0.1
+record_version:
+record_id: AC-001
+title: Acceptance Criteria
+---
+
+# Acceptance Criteria
+<!-- [13485:7.1c,7.2.3c,7.3.6,7.3.7,7.5.6c]-->
+
+## General
+
+|                           |               |
+|---------------------------|---------------|
+| **Template ID**           | CSC F.026     | 
+| **Template Version**      | 2.0.1         |
+| **QMS Version**           | 2.2.0         |
+| **SOP ID**                | CSC PR.012    |
+| **SOP Version**           | 2.0.1         |
+| **Regulatory References** |               |
+
+
+|              |              |
+|--------------|--------------|
+| **Author**   |              |
+| **Approval** |              |
+
+## Purpose 
+
+This document lists the tasks to be finalised, completed and approves before the application can be released to the 
+host department for routine clinical use. 
+
+
+## Scope
+
+This document applies to {{device.name}} release {{device.version}}.
+
+## Definitions
+
+| Term  | Definition  |
+|-------|-------------|
+|       |             |
+|       |             |
+
+## Introduction
+
+## Criteria 
+
+[TODO: append any other application tasks for the safe deployment of the application as agreed with the host department]
+
+| No. | Item                                           | Signed | Date |
+|-----|------------------------------------------------|--------|------|
+| 1   | Clinical safety case report approved           |        |      |
+| 2   | All verification tests passed or justified     |        |      |
+| 3   | All validation tests passed or justified       |        |      |
+| 4   | Application deployed                           |        |      |
+| 5   | Work instructions & Label provided             |        |      |
+| 6   | Service Level Agreement signed by both parties |        |      |
+| 7   | Risk assessment provided                       |        |      |
+| 8   | Retrospective evaluation completed             |        |      |
+| 9   | Prospective evaluation completed               |        |      |
+| 10  | Audit cycle and frequency confirmed            |        |      |
+| 11  | Post deployment surveillance plan confirmed    |        |      |
+| 12  | Communication channels confirmed               |        |      |
+|     |                                                |        |      |
+
diff --git a/documentation/documents/clinical_risk_management_plan.md b/documentation/documents/clinical_risk_management_plan.md
@@ -1,35 +1,36 @@
 ---
-test: 123
+qms_version: 2.2.0
+sop_id: CSC PR.002
+sop_version: 2.0.1
+template_id: CSC F.009
+template_version: 2.0.1
+record_version: 
+record_id: CRMP-001
+title: Clinical Risk Management Plan
 ---
 
 # Clinical Risk Management Plan
 
 ## General
 
----
-test: 123
-Document: ID              
-Author:            
-Revision:         
-Regulatory References:
----
-
-
-
-
-|                           |     |
-|---------------------------|-----|
-| **Document ID**           |     |
-| **Author**                |     |
-| **Revision**              |     |
-| **Regulatory References** |     |
-
+|                           |              |
+|---------------------------|--------------|
+| **Template ID**           | CSC F.009    |
+| **Template Version**      | 2.0.1        |
+| **QMS Version**           | 2.2.0        |
+| **SOP ID**                | CSC PR.002   |
+| **SOP Version**           | 2.0.1        |
+| **Regulatory References** |              |
 
 
+|              |              |
+|--------------|--------------|
+| **Author**   |              |
+| **Approval** |              |
 
 ## Scope
 
-This document applies to the {{device.name}} release {{device.version}}. 
+This document applies to the {{device.name}} version {{device.version}}. 
 
 ## Purpose
 
@@ -54,7 +55,7 @@ The document also provides traceability for risk controls throughout the project
 |----------------------------------|----------|
 | Hazard Log                       | HZ-001   |
 | Clinical Safety Case Report      | CSCR-001 |
-| Verification and Validation Plan | V&V-001  |
+| Verification and Validation Plan | VVP-001  |
 
 
 ## Definitions
@@ -167,10 +168,12 @@ Table X described the acceptability of estimated risks
 
 
 ### Risk Controls
+<!-- [13485:7.2.1a]-->
 
 Where risks exceed the acceptable level, risk controls will be implemented to reduced/remove likelihood of the causes of
-the hazard occurring.
-The effectiveness of each risk control with be verified with a unit test or a manual validation test. 
+the hazard occurring. Risks controls will be reflected a new system requirement item and system design item if not 
+already represented. The effectiveness of each risk control with be verified with a unit test or a manual validation 
+test. 
 
 ### Evaluation of overall residual risk
 
@@ -184,6 +187,7 @@ When the application development has finished and the clinical investigation has
 amendments to the Hazard Log, a Clinical Safety Case report will be approved by CSO. 
 
 ### Deployment and Post-Deployment Activities
+<!-- [13485:7.2.1a]-->
 
 During and after deployment the hazard log will be updated in response to incidents, near misses and post deployment
 surveillance activities.