Medical device compliance AI you can trust
We analyze, audit, and generate regulatory documentation for medical device companies. Get audit-ready documentation in days, not months.
The Problem
Compliance documentation is overwhelming
Whether you're preparing for an audit, updating your technical file, or addressing gaps in your QMS:
- Manual documentation takes months
- Consultants charge €200,000+ annually
- Every change requires extensive updates
- You're never sure if you're fully compliant
Compliance shouldn't consume all your resources.
Our Solution
AI-powered compliance documentation service
What We Do
Complete compliance documentation support
📋 Gap Analysis & Audits
Identify what's missing, what needs updating, and what's non-compliant
📄 Documentation Generation
Technical files, clinical evaluations, risk management, SOPs — any document you need
🔄 Updates & Maintenance
Keep your documentation current with product changes and regulatory updates
✓ Compliance Review
Ensure everything meets MDR, ISO 13485, and other requirements
How We Work
Fast, flexible, reliable
Real-World Scenarios
How we help medical device companies
Pre-audit preparation — Identify and fix gaps before your audit
Technical documentation — Complete technical Documentation for CE marking
QMS development — Enhance your quality system
Document updates — Revise documentation for product changes
Regulatory transitions — Update legacy documentation for MDR
Gap remediation Address non-conformities and findings
Emil Timmreck Pedersen
Founder & CEO
Emil is a former IT Compliance Consultant at Novo Nordisk Pharmatech and SaMD QA consultant at INVIXO Consulting Group, with 4+ years specializing in IT/SaMD QMS development.
He holds a Master of Science in Business Administration and Information Systems and a Master of Science in Political Science.