AI-powered eQMS & ERP for regulated MedTech

Streamline quality, compliance, and operations. Designed to support FDA 21 CFR Part 11 and ISO 13485 processes.

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AI-powered technology company
Revolutionizing compliance & operational efficiency
Focus on MedTech, digital health, and life sciences

Product

AI-Powered eQMS

Document control, training, CAPA, complaints, audits—assisted by AI for speed and consistency.

AI-Powered ERP

Inventory, purchasing, work orders, and traceability that connect directly to quality events.

Quantum-Ready Security

Modern cryptography today, with a roadmap toward quantum-resilient practices.

Compliance Alignment

Akunyx is designed to support your quality system processes and recordkeeping in alignment with FDA 21 CFR Part 11 and ISO 13485. Akunyx itself is not a certification body.

FDA 21 CFR Part 11 → ISO 13485 → 21 CFR Part 820: Quality System Regulation → ISO 14971:2019 - Risk Management → IEC 62304:2006 - Software Life Cycle → ISO/IEC 27001:2022 - Information Security →

Leadership

Meet the team building usable compliance for regulated MedTech.

About Akunyx →

Get in touch

Email us at hello@akunyx.ai or use the form below.