# MedDevo

> Regulatory documentation platform for medical devices and in vitro diagnostics (IVDs). MedDevo digitizes and automates technical documentation, compliance workflows, and regulatory processes for the EU MDR and IVDR.

## Company Overview

MedDevo is a regulatory technology (RegTech) company founded in 2017 and headquartered in Fulda, Germany. The company builds an enterprise-grade platform that transforms how medical device manufacturers create, manage, and maintain their regulatory documentation.

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

**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.

### Key Facts

- Founded: 2017
- Headquarters: Frankfurter Str. 15, 36043 Fulda, Germany
- CEO: Michael M. Kania
- CTO: Matthias Risto
- Server location: Frankfurt a.M., Germany
- 130,000+ medical devices managed on the platform
- 120 years combined regulatory experience in the team

### Regulatory Focus

- EU Medical Device Regulation (MDR)
- EU In Vitro Diagnostic Regulation (IVDR)
- DIN SPEC 91509 (data model for digital technical documentation)
- ISO/TR 80002-2 compliance
- 21 CFR Part 11 compliance
- GDPR compliance

## Products

### eTD - Electronic Technical Documentation

MedDevo's flagship product. A content-based technical documentation platform that replaces static document-centric approaches with structured, reusable regulatory data.

- 1,700+ structured data endpoints
- Eliminates 424 redundant content positions per technical documentation
- Automates up to 80% of documentation work
- Live impact analysis before changes
- Automated compliance monitoring
- Built on the DIN SPEC 91509 data model

URL: https://meddevo.com/products/etd

### eIFU - Electronic Instructions for Use

A digital platform for publishing and managing electronic instructions for use, compliant with EU regulations for paperless IFU distribution.

URL: https://meddevo.com/products/eifu

### RegulatoryAI

AI-powered regulatory writing assistant integrated into the MedDevo platform. Helps regulatory affairs professionals draft and review documentation with domain-specific AI capabilities.

### DocHub

Secure document distribution portal for sharing regulated documents with external stakeholders such as notified bodies, authorities, and business partners.

URL: https://meddevo.com/products/dochub

## Solutions

### Digital Standards

Digitized management of regulatory standards (harmonized standards, common specifications) with automated tracking of standard updates and their impact on technical documentation.

URL: https://meddevo.com/solutions/digital-standards

### Submission Management

Streamlined workflows for preparing and managing regulatory submissions to notified bodies and competent authorities.

URL: https://meddevo.com/solutions/submission-management

### UDI Data Management

Management of Unique Device Identification (UDI) data, including integration with EUDAMED and other UDI databases.

URL: https://meddevo.com/solutions/udi-data-management

### Essential Notification Body Requirements (ENB)

Module for managing and tracking essential requirements for notified body audits and conformity assessments.

URL: https://meddevo.com/solutions/enb

### Clinical Evaluation

Automated creation and maintenance of Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP) with structured literature management.

URL: https://meddevo.com/solutions/clinical-evaluation

### Risk Management

Automated generation and maintenance of Risk Management Plans (RMP) and Risk Management Reports (RMR) integrated with technical documentation data.

URL: https://meddevo.com/solutions/risk-management

## Standards & Expertise

### DIN SPEC 91509

MedDevo is a key contributor to DIN SPEC 91509, the standardized data model for digital medical device technical documentation. The MedDevo Knowledge Unit (MDKU) includes a validator tool for checking compliance with this specification.

- [DIN SPEC 91509 Info](https://meddevo.com/mdku/din-spec-91509)
- [MDKU Validator](https://meddevo.com/mdku)

## Enterprise Features

- Single Sign-On (SSO) via WorkOS AuthKit
- Multi-factor authentication (MFA)
- Audit trails and approval workflows
- Role-based access control
- Data residency in Germany (Frankfurt a.M.)
- GDPR-compliant data processing

## Target Audience

Medical device and IVD manufacturers across Europe, from small and medium-sized enterprises (SMEs) to large enterprises. Particularly relevant for companies that:

- Need to comply with EU MDR or IVDR
- Want to digitize their technical documentation
- Are transitioning from document-based to data-based regulatory processes
- Need to manage multiple product variants or device families efficiently

## Notable Customers

Henry Schein, Loewenstein Medical, Windstar Medical + Merz, ulrich medical, Kulzer, AKRA TEAM, metecon, qtec

## Contact & Demo

- Request a live demo: https://meddevo.com/demo
- Blog: https://meddevo.com/blog

## Legal

- Imprint: https://meddevo.com/imprint
- Privacy Policy: https://meddevo.com/privacy-policy
- Terms of Use: https://meddevo.com/terms-of-use

meddevo GmbH, Frankfurter Str. 15, 36043 Fulda, Germany
Amtsgericht Fulda HRB 9251 | USt-IdNr: DE319358050