Description:
Medical device manufacturers operating under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) frameworks, are required to produce extensive technical documentation demonstrating safety, performance, and regulatory compliance.
In many organizations, this documentation is still partially managed through manual editing of Word or PDF files, which increases the risk of inconsistencies, broken traceability, and non-compliant changes.
This project aims to develop an Automated Regulatory Documentation System that enforces a Single Source of Truth (SSOT) for all regulatory artifacts. The system will generate compliant documents programmatically, validate cross-references automatically, and maintain a complete traceability graph linking requirements, hazards, specifications, and verification evidence.
A central innovation of the system is the technical enforcement of document integrity: final documents will include regulatory watermarks containing Git commit hashes, making any manual or untracked modification immediately detectable. The objective is to eliminate undocumented changes and guarantee full traceability for certification and audit processes.
Why This System is Needed
Regulatory compliance under MDR and IVDR requires strict alignment between design inputs, risk management, verification activities, and final documentation. Any inconsistency between these artifacts can delay certification, increase audit findings, or expose the company to regulatory risk. Traditional documentation workflows often rely on manual updates, copy-paste operations, and disconnected spreadsheets, which make traceability verification time-consuming and error-prone.
An automated system that enforces structured relationships between regulatory elements can:
- Ensure completeness and coverage of requirements
- Automatically validate relationships between hazards, mitigations, and test cases
- Detect missing references or duplicate identifiers
- Provide auditable proof of documentation integrity
The goal is to shift regulatory documentation from a static document-based workflow to a structured, validated, and enforceable engineering system.
How We Plan to Achieve It
To obtain acceptable results, the project has been divided into four main phases:
1. Regulatory Mapping and System Definition
The first phase will define the regulatory scope of the system based on MDR/IVDR requirements and internal corporate templates. The core document types (e.g., requirements specifications, risk management files, verification reports) will be analyzed to identify mandatory fields, relationships, and traceability expectations. A data model will be defined to represent requirements, hazards, specifications, test cases, and their relationships as a structured traceability graph. Validation rules for uniqueness, cross-referencing, and coverage will be specified at this stage.
2. Architecture and Traceability Engine Design
The system architecture will be designed around a Single Source of Truth principle. All regulatory elements will be stored in a structured data model rather than directly edited documents.
A traceability engine will be implemented to maintain and validate the graph of relationships between artifacts. The system will automatically check for broken links, duplicate IDs, and incomplete coverage of regulatory requirements. A generation engine will be designed to produce Word or PDF documents compliant with corporate templates using Content Controls, ensuring that documents are always generated from validated structured data rather than manually edited.
To reinforce integrity, generated documents will include regulatory watermarks embedding Git commit hashes, allowing precise traceability to the source data state at the time of generation.
3. Implementation and CI/CD Integration
In this phase, the structured editor, traceability engine, and document generation pipeline will be implemented. A web-based structured editor will allow controlled input of regulatory artifacts, preventing free-form modifications that could compromise consistency. A visualization dashboard will present the traceability graph, enabling intuitive navigation between requirements, risks, and verification evidence. The system will also integrate into a CI/CD pipeline, where validation checks will run automatically. Documentation builds will fail if validation rules are violated, effectively blocking non-compliant documentation from being finalized.
This phase will result in a functional prototype capable of generating validated, auditable regulatory documentation end-to-end.
4. Validation, Audit Simulation, and Documentation
The final phase will focus on validating the system against realistic documentation scenarios. Test datasets will be used to simulate regulatory workflows and verify that traceability coverage, ID uniqueness, and cross-document references are consistently enforced. An audit simulation scenario will be performed to demonstrate how the system supports regulatory inspections by providing clear traceability visualization and version-controlled documentation outputs. Comprehensive technical documentation will describe the system architecture, validation mechanisms, generation process, and CI/CD integration.
The final outcome will be a working prototype demonstrating automated regulatory documentation with enforced traceability, audit readiness, and protection against unauthorized modifications.
Project Timeline
- Regulatory Mapping and System Definition: 40–60 hours
- Architecture and Traceability Engine Design: 80–90 hours
- Implementation and CI/CD Integration: 100–120 hours
- Validation and Documentation: 50–60 hours
Total Time Frame: 270-330 hours