Modern eQMS & ERP for product-led, fast-moving MedTech innovators
AI-powered quality management that unifies compliance, operations, and product development. Built for engineers, trusted by auditors, designed to scale.
Key Features
Everything you need to build, ship, and scale compliant medical devices
Design and Development
Digitally manage your DHF with built-in traceability between design inputs, outputs, verifications, and product risk controls, plus AI-powered suggestions.
Compliance and Risk Management
Track and manage operational risk across your QMS – from regulatory requirements to audit readiness and CAPA trends.
Documents and Training
Control documents, changes, and training in one place – with automated routing, audit trails, and role-based access.
Quality Processes
Log, track, and resolve quality events in a connected system that links CAPAs, training, and documentation.
Clinical Data Management
Capture compliant, audit-ready clinical data across every phase of your study - from first-in-human to post-market.
AI-Powered ERP
Inventory, purchasing, work orders, and traceability that connect directly to quality events.
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.
Why Akunyx?
Made for medical devices
Get software built specifically for your business needs, backed by experienced industry experts.
Guided implementation
Measure time-to-value in weeks—not months or years—as you work through your personalized implementation plan.
Built for growth
Whether you're developing your first device or managing a portfolio on the market, Akunyx is designed to support you now and in the future.
Smart by design
Move faster with AI-powered solutions that ease the workload and help prevent compliance surprises.
Get in touch
Email us at hello@akunyx.ai or use the form below.