Design History File — Master Index

Document Control

Document ID	DHF-001
Version	1.0
Date	2026-03-22
Author	camt053 Engineering
Status	Released
Classification	Internal

Purpose

This Design History File (DHF) provides ISO 13485:2016-equivalent documentation rigor for the camt053 library — a Python library that reads ISO 20022 camt Bank-to-Customer Cash Management messages (camt.052 Account Report, camt.053 Bank to Customer Statement, camt.054 Debit Credit Notification), extracts booked entries by return reason code, and generates validated reversing entries.

While camt053 is financial infrastructure software rather than a medical device, this DHF applies the same systematic design control discipline required by ISO 13485:2016 clause 7.3 to demonstrate that the software was developed under a controlled, traceable, and verified process. This approach satisfies institutional audit requirements and establishes readiness for regulated deployment environments, including Banking-as-a-Service (BaaS) and embedded finance platforms.

Scope

• Product: camt053 Python library

• Version: 0.0.5

• Message standard: ISO 20022 camt.052/053/054 Bank-to-Customer Cash Management (read; reversing entries emitted as camt.053.001.14)

• IEC 62304 safety classification: Class A (voluntary Class C processes applied)

Document Set

#	ID	Document	ISO 13485 Clause
1	DHF-001	Design History File — Master Index (this document)	7.3.10 (DHF overview)
2	DHF-002	Design and Development Plan	7.3.1, 7.3.2
3	DHF-003	Software Requirements Specification	7.3.3
4	DHF-004	Software Architecture Document	7.3.4
5	DHF-005	Risk Management File	7.3.4, ISO 14971, IEC 62304
6	DHF-006	Verification and Validation Plan	7.3.5, 7.3.6, 7.3.7
7	DHF-007	Traceability Matrix	7.3.10
8	DHF-008	Design Review and Change Control	7.3.4, 7.3.9
9	DHF-009	Configuration Management and Design Transfer	7.3.8, 4.2.3

DHF Documents

• Design and Development Plan
  • 1. Scope
  • 2. Applicable Standards
  • 3. Development Methodology
  • 4. Development Phases
  • 5. Tools and Environment
  • 6. Quality Gates
  • 7. Deliverables
• Software Requirements Specification
  • 1. Functional Requirements
  • 2. Non-Functional Requirements
• Software Architecture Document
  • 1. Module Architecture
  • 2. Data Flow
  • 3. Parsing and Reversal Strategy
  • 4. Exception Hierarchy
  • 5. Security Architecture
  • 6. Interface Specifications
  • 7. Design Decisions and Rationale
• Risk Management File
  • 1. IEC 62304 Safety Classification
  • 2. Risk Analysis Methodology
  • 3. Risk Register
  • 4. Risk Control Verification
  • 5. Residual Risk Assessment
• Verification and Validation Plan
  • 1. Test Strategy
  • 2. Test Categories and Markers
  • 3. Test File Inventory
  • 4. Conformance Against Official ISO Business Samples
  • 5. Static Analysis Tools
  • 6. CI Pipeline
  • 7. Acceptance Criteria
• Traceability Matrix
  • 1. Forward Traceability: Requirement to Implementation to Test
  • 2. Reverse Traceability: Test File to Requirements
  • 3. Risk Control Traceability
• Design Review and Change Control
  • 1. Design Review Records
  • 2. Change Control Log
  • 3. Design Change Process
• Configuration Management and Design Transfer
  • 1. Version Control
  • 2. Commit Policy
  • 3. Pre-commit Hooks
  • 4. Configuration Items
  • 5. Baseline Definition
  • 6. Release Process Checklist
  • 7. Deployment Architecture

Standards Compliance Cross-Reference

Standard	Clause	DHF Coverage
ISO 13485:2016	7.3.1	DHF-002 Design and Development Planning
ISO 13485:2016	7.3.2	DHF-002 Design and Development Inputs
ISO 13485:2016	7.3.3	DHF-003 Software Requirements Specification
ISO 13485:2016	7.3.4	DHF-004 Software Architecture, DHF-005 Risk Management
ISO 13485:2016	7.3.5	DHF-006 Verification and Validation Plan
ISO 13485:2016	7.3.6	DHF-006 Design Validation
ISO 13485:2016	7.3.7	DHF-008 Design Review and Change Control
ISO 13485:2016	7.3.8	DHF-009 Configuration Management and Design Transfer
ISO 13485:2016	7.3.9	DHF-008 Design Changes
ISO 13485:2016	7.3.10	DHF-001 (this document), DHF-007 Traceability Matrix
ISO 13485:2016	4.2.3	DHF-009 Document Control
ISO 14971:2019	All	DHF-005 Risk Management File
IEC 62304:2006+A1	All	DHF-002 through DHF-009

Approval Signatures

Role	Name	Signature	Date
Lead Engineer
Quality Assurance
Regulatory Affairs