Stop chasing audit evidence. Ship medical devices with confidence.
Komplyon is the autonomous compliance copilot that continuously evidences your AWS infrastructure and AI-powered medical devices against ISO 13485, IEC 62304, EU MDR, and the EU AI Act — built in Germany for European medtech teams.
Built for the regulations medical device companies actually face
ISO 13485 evidence on autopilot
Continuous evidence collection for QMS clauses 4.2.4, 7.5.8, and the cloud-infrastructure aspects of design controls — ready for your TÜV Süd or Dekra audit.
IEC 62304 software lifecycle
Verify configuration management, immutable releases, traceability from requirements to deployment, and risk control measures across your AWS environment.
EU MDR Annex II Technical File integration
Generate audit-ready evidence packs that map directly to MDR Annex II sections — no more spreadsheets the night before a notified body audit.
EU AI Act for SaMD with AI
AI-powered medical devices fall under EU AI Act high-risk obligations. Komplyon classifies your AI systems and continuously evidences Art. 9, 10, 12, 14 compliance.
Built for medical device companies like
Coming soon — design partners launching Q3 2026
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