About meddevo

We simplify regulatory documentation for medical devices

Unlike traditional document management systems, we built a content-first platform that understands medical device regulations and automates compliance workflows.

Our Story

How it all started

We started meddevo because we experienced firsthand how frustrating regulatory documentation can be. As regulatory affairs professionals ourselves, we spent countless hours manually updating documents, chasing version histories, and preparing submissions.

The tools available were either overly complex enterprise systems or simple file storage that didn't understand regulatory requirements. We knew there had to be a better way.

So we built meddevo — a platform that thinks in regulatory content, not just documents. One that automates the tedious work and lets you focus on what matters: getting safe medical devices to patients.

meddevo team working together

Started

2017

Growing since

Mission & Vision

What we aim to achieve

Our Mission

To eliminate the complexity of regulatory documentation so medical device companies can focus on innovation and patient safety.

  • Reduce documentation time by 80%
  • Eliminate compliance gaps
  • Automate repetitive tasks

Our Vision

A world where regulatory compliance is an enabler, not a barrier. Where every medical device company, regardless of size, has access to enterprise-grade regulatory tools.

  • Democratize regulatory technology
  • Set the new industry standard
  • Enable faster time-to-market
Leadership

Meet our founders

A team with decades of combined experience in regulatory affairs, medical devices, and software development.

Michael M. Kania

Michael M. Kania

CEO, Founder

Matthias Risto

Matthias Risto

CEO, Founder

Our Journey

Milestones achieved

From humble beginnings to serving medical device companies across the globe.

2017

The Beginning

Started with a vision to simplify regulatory processes for medical device companies.

2020

First Product Launch

Launched our core eTD platform, helping companies manage technical documentation digitally.

2021

Automation Features

Developed and released the meddevo Writer, introducing automation to document creation.

2022

Major Expansion

Expanded our solution suite with eSubmissions, and Standard Management capabilities.

2024

AI-Powered Innovation

Introduced RegulatoryAI to enhance compliance tasks and accelerate documentation workflows.

2025

eIFU

Release of our electronic Instructions for Use (eIFU) and building the foundation for next generation IFU.

Our Impact

Numbers that speak for themselves

130k+

Devices Managed

1.700+

Data Endpoints in eTD

120

Years of Experience

Endless Hours Saved

Ready to transform your regulatory workflow?

Join 130.000 medical devices that are already streamlined with meddevo.