ISO 13485

What it requires

ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. For AI-powered medical devices, this includes software lifecycle management, design controls, and risk management.

Key clauses for AI medical devices

• Clause 4.2: Documentation requirements for the quality management system
• Clause 7.1: Planning of product realisation and software development processes
• Clause 7.2: Customer-related processes and regulatory requirements determination
• Clause 7.3: Design and development controls (inputs, outputs, review, verification, validation, transfer)
• Clause 7.5: Production and service provision, including software validation
• Clause 7.6: Control of monitoring and measuring equipment
• Clause 8.2: Monitoring and measurement, including post-market surveillance
• Clause 8.5: Improvement, including CAPA (corrective and preventive action)

How Vigilens automates it

Vigilens maps ISO 13485 design controls to the AI development pipeline. Where traditional QMS tools treat software as a static artefact, Vigilens tracks the AI model lifecycle continuously: from training data governance through deployment, monitoring, and retraining.

• Design control stages (inputs, outputs, review, V&V) mapped to pipeline events
• Risk management evidence linked to ISO 14971 requirements via EU MDR
• Software lifecycle evidence collected from version control and CI/CD logs
• Change control and CAPA tracking with continuous traceability
• Cross-mapped to EU MDR Annex I essential requirements

ISO 13485 and AI in medtech

AI-powered medical devices face unique challenges under ISO 13485: continuous learning models challenge traditional design freeze requirements, and training data governance demands evidence beyond what conventional QMS tools collect. Vigilens bridges this gap by maintaining a living quality record that reflects the current state of the AI system, not just its initial design.