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 files for CE marking
QMS development — Build your quality system from scratch
Document updates — Revise documentation for product changes
Regulatory transitions — Update legacy documentation for MDR
Gap remediation Address non-conformities and findings
Anton Høier Danielsen
CTO
Anton has 5 years of experience with programming software at Novo Nordisk and Novonesis. The experience has brought him insights, and practical experience, with the complexity and importance of documentation for medical devices developers.
He holds a Bachelor’s degree in marine engineering and technology management.
Emil Timmreck Pedersen
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.
Yuri Tymoshchuk
CPO
Yuri has over 10 years of experience as a software engineer, collaborating with leading companies such as Maersk, UNDO, and Too Good To Go.
He is specialized in designing and delivering scalable, user-centric solutions, with a proven track record of leading cross-functional projects from concept to successful deployment. He holds a Master’s degree in Mathematics.