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Engineering intelligence
that gets your tech to market

Expert guidance at every step.
Documentation from the work itself.

How it works

Get answers when you need them. Not tomorrow.

Your work becomes your documentation.

Change your design. Everything updates.

How do I validate Class II software?

You'll need a V&V Plan per IEC 62304, requirements traceability matrix, test protocols, and risk management documentation per ISO 14971.

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Assistant

Your Expert, Always Available

AI copilot for design decisions and regulatory requirements. Instant, context-aware.

Risk Management Plan

Document ID: RMP-2024-003

Hazard Analysis

The following hazards have been identified through FMEA analysis...

Electrical Hazards (IEC 60601-1): Risk of electric shock, excessive leakage current...

Workspace

Design and Document Together

Create compliant docs with AI. Full lifecycle traceability built in.

Quality Management

24 Active · 156 Closed

CAPA-2024-0847

Closed

Calibration deviation detected on equipment QC-220

Quality Team · Resolved

✓

Analysis

✓

Action

✓

Verification

Vault

Quality Management Made Simple

Complete eQMS for CAPAs, NCRs, complaints, and audits. Automated traceability.

✓

Requirements

✓

Design

✓

Verification

Validation

Generated Deliverables

✓ Audit-Ready

Requirements Spec

Design Docs

Test Protocols

Validation Report

Workflows

Automate Your Process

Multi-model agents automate compliance workflows. Audit-ready output.

Security & Compliance

Enterprise-grade security with internationally recognized certifications.

SOC 2 Type II

Third-party security audits

ISO/IEC 27001:2022

Information security management

ISO/IEC 42001:2023

AI management system standard

AES-256 Encryption

Military-grade data protection

GDPR & CCPA

Global privacy compliance

Zero Retention

No data storage or training

The methodology is required.

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