# 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
- 270,000+ 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)

### DIGICAP

DIGICAP is a Horizon Europe project (2026 to 2029) building an open data framework for MDR and IVDR conformity assessment. What it is, what it is not, and what RA and QM teams can do now. meddevo takes part as an invited software vendor.

- [DIGICAP explained](https://meddevo.com/digicap)

## 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