meddevo

What meddevo does

meddevo GmbH is a German medtech SaaS company, founded in 2018 and headquartered in Fulda, that provides a content-based electronic Technical Documentation (eTD) platform for medical device and in vitro diagnostic (IVD) manufacturers operating under EU MDR 2017/745 and IVDR 2017/746. The platform is differentiated by a content-based regulatory data model — built on the MDKU (Medical Device Knowledge Units) data model aligned with DIN SPEC 91509, of which meddevo is a co-author via its founding role in MDKU e.V. — rather than a document-based paradigm. This architecture functions as a Single Source of Truth that automatically propagates changes across all connected documents, enables live impact analysis, and powers continuous completeness monitoring for technical documentation submissions.

The product suite comprises two core solutions and 15+ modules: meddevo eTD (technical documentation), meddevo eIFU (electronic instructions for use with multi-language and QR-based publishing), RegulatoryAI (LLM-augmented medical writing and document digitalization), eStandards, GSPR Manager, eSubmissions, eNB (Notified Body portal, in research), UDI Management, DocHub, Approval Workflows, Clinical Evaluation, Risk Management, and others. The platform is delivered as validated SaaS with EU data residency, ISO 27001 certification, GDPR compliance, 21 CFR Part 11 readiness, and ISO/TR 80002-2 validation. Integration is provided via a REST API connecting to ALM, PLM, and ERP systems, with Microsoft Entra SSO.

Revenue is generated through a SaaS subscription model with a freemium entry point ("Start free and scale as you grow") and quote-based enterprise pricing. Distribution is sales-led and consultative, targeting regulatory affairs professionals at medical device/IVD manufacturers — primarily in Europe but with claimed presence in the US, UK, Brazil, and Australia. Named customers include Henry Schein, Löwenstein Medical, PHS Medical, Windstar Medical, ViennaLab, Albomed, and Joline, with over 130,000 medical devices managed on the platform. The go-to-market blends direct enterprise sales with content marketing, webinars, MEDICA trade show presence, and a regulatory academy (RAcademy). No venture funding rounds have been disclosed; in March 2026, Dr. Bassil Akra joined as strategic shareholder, marking the company's first formal external capital event.

Name

meddevo

Legal name

meddevo GmbH

Website

https://meddevo.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

meddevo is a German SaaS company providing a content-based electronic Technical Documentation platform for medical device and IVD manufacturers, built on the MDKU data model (DIN SPEC 91509) to automate EU MDR/IVDR compliance, with 130,000+ devices managed across named enterprise and mid-market customers in Europe.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Compliance Software

NAICS

Computer Systems Design Services (541512), Other Computer Related Services (541519), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Prepackaged Software (7372), Services-Health Services (8000)

akta.pro primary industry

Healthcare Terminology, Ontology & Code Set Management (SNOMED/LOINC/ICD/RxNorm) (HLACAIAF)

akta.pro secondary industry

Clinical Coding Support (ICD/CPT/SNOMED) & Documentation Compliance Tools (HLACAAAO)

Keywords

• Medical device documentation
• Regulatory compliance software
• Technical documentation management
• MDR IVDR compliance
• Regulatory data management

Headquarters

HQ city

Fulda

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Marketing or Sales, Operations, Infrastructure

Revenue model

1. SaaS Subscription - meddevo eTD: Subscription-based SaaS model for the core eTD platform. Pricing is quote-based with 'Start free and scale as you grow' positioning. No setup fees or hidden costs mentioned. Enterprise-grade platform with validated server environment.
2. SaaS Subscription - meddevo eIFU: Electronic Instructions for Use platform with free start option and scaling as needed. No setup fees, no hidden costs.
3. Additional Modules (eStandards, RegAI, DocHub): Additional regulatory modules and AI features available as part of the platform suite or potentially as add-ons to the core subscription.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

meddevo provides a SaaS platform for digital, content-based regulatory technical documentation of medical devices and IVDs. Its flagship product meddevo eTD manages structured regulatory data (not static documents) to enable automated document generation, live impact analysis, and continuous completeness monitoring across MDR, IVDR, and global frameworks. It is complemented by meddevo eIFU for electronic Instructions for Use, meddevo RegulatoryAI for AI-assisted medical writing, and add-on modules such as eStandards, GSPR Manager, eSubmissions, DocHub, and UDI Management.

Product overview

meddevo is a Medtech Digitalization Platform offering a suite of independent solutions built on a unified eTD (Electronic Technical Documentation) data model. The core platform includes meddevo eTD for content-based technical documentation and meddevo eIFU for electronic instructions for use. These are augmented by specialized modules including RegulatoryAI (AI-powered regulatory assistance), eStandards (digital standards management), eSubmissions (submission management), eNB (Notified Body portal), GSPR Manager, Document Writer, Approval Workflows, SOP Management, CAPA & Changes, Clinical Evaluation, Risk Management, UDI Management, DocHub, and RegAI. An upcoming module called eDesign is in development. All solutions share one source of truth through the eTD data model, enabling automation and consistency across MDR, IVDR and global regulatory frameworks. The platform is designed for medical device manufacturers managing complex portfolios.

Differentiator

Problem solved

Functional benefit

Products and services

• meddevo eTD (Electronic Technical Documentation) Flagship content-based technical documentation platform for medical-device and IVD manufacturers managing complex portfolios across multiple markets. Builds technical documentation from structured regulatory data, automatically generates and maintains documents, monitors completeness across MDR, IVDR and global frameworks, creates submissions from validated snapshots, and manages global variations without redundancy.
• meddevo eIFU (Electronic Instructions for Use) Complete electronic instructions-for-use platform for digital document management across markets. Provides multi-language IFU management with automated publishing, QR code generation, public website hosting with custom domain support, version control and audit trail, and full compliance with EU 2021/2226 and MDR/IVDR.
• meddevo RegulatoryAI AI-powered regulatory-affairs assistant that digitizes technical documentation and supports medical writing. Combines large language models with company-specific regulatory knowledge for accurate, compliant content generation, including drafting, regulatory Q&A, document data extraction and compliance guidance.
• meddevo eStandards Digital standards management solution that automates standard management and document updates, centralizes standards, MDCG guidelines, and regulatory-requirement tracking with automated impact assessments and document updates.
• meddevo eSubmissions Submission management solution for creating and managing regulatory submissions across multiple markets and frameworks from validated eTD snapshots.
• meddevo DocHub (Document Hub) Document hub module providing centralized document management, multilingual content management, and collaborative features for regulatory teams as part of the meddevo ecosystem.
• meddevo UDI Management Unique Device Identification data management solution for managing UDI data in line with MDR/IVDR requirements.
• meddevo eNB European Notified Body submission portal platform under research/development, enabling 100% digital submission from manufacturer to Notified Body with automated pre-assessment for medical-device and IVD conformity assessments.
• MDKU Validator Free tool that validates XML files against the DIN SPEC 91509 (MDKU) schema, allowing users to upload XML data and confirm device data is compliant before submission.
• meddevo GSPR Manager General Safety and Performance Requirements module for MDR/IVDR, managing automated GSPR checklists, alignment with safety/performance requirements, and compliance tracking.

Quantifiable outcome

• Over 130,000 medical devices already managed on the platform
• +3 more outcomes

Named customers9 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

AI capability4 records

Feature7 records

Partnerships

Five partnerships are on record, tiered strategic, core and supporting.

• MeteconstrategicStrategic or Co-development Partner · 10 February 2026Partnership for Digital Technical Documentation between Metecon and meddevo. Metecon is a regulatory consulting and services company for medical devices and IVDs. The partnership aims to advance digital technical documentation solutions.
• Medical MountainscoreStrategic or Co-development Partner · 1 November 2025Regional partnership with Medical Mountains, Germany's premier medtech cluster organization. Strengthens meddevo's dedication to regional innovation and collective growth within German medtech. Collaboration includes networking exchanges and best practice sharing.
• MDKU e.V.coreStrategic or Co-development Partner · 1 January 2021MDKU e.V. (Medical Device Knowledge Units) is a German nonprofit association maintaining a standardized data model for structuring technical documentation content. meddevo is a founding member and has been involved in shaping DIN SPEC 91509 from the beginning. The MDKU data model defines Knowledge Topics (regulatory templates) and Knowledge Units (device-specific content), published under DIN SPEC 91509.
• DIN e.V.supportingOthersDIN e.V. (German Institute for Standardization) supported the development of DIN SPEC 91509. Published the specification under the PAS procedure in February 2026.
• SPECTARISsupportingOthersGerman industry association for medical technology that supports the MDKU initiative and standardization efforts in medtech.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Veeva Systems: Dominant life sciences SaaS platform with Vault QualityDocs and Vault RegulatoryDocs serving pharma and medtech regulatory teams globally. Veeva is the most established incumbent in regulated content management for life sciences, competing for the same buyer (Head of Regulatory Affairs) but at much broader enterprise scale.
• ETQ (Hexagon): Enterprise QMS platform owned by Hexagon, serving regulated industries including medical devices. Larger and more horizontal than meddevo, but competes for the same enterprise medtech customer with quality and document management capabilities.
• Sparta Systems (Honeywell): TrackWise QMS, now part of Honeywell, serves pharma and medtech with quality, regulatory, and document management. A broader incumbent competing for the same regulated-content buyer at enterprise scale.
• PTC Windchill: Enterprise PLM platform widely used in regulated industries, with capabilities for design controls, regulatory submissions, and technical documentation. A broader incumbent that competes for the same manufacturer-side regulatory data use case.

Direct peers

• MasterControl: Direct competitor in quality and regulatory document management for medical device manufacturers, with eDMS, QMS, and submission management capabilities. Closest analog to meddevo's eTD offering, particularly for mid-market medtech companies needing MDR/IVDR-aligned workflows.
• Greenlight Guru: Medtech-specific QMS and eDMS platform with strong US-centric positioning and MDR/IVDR modules. Targets the same medical device manufacturer buyer with quality and design controls, overlapping directly with meddevo's technical documentation use cases.
• Qualio: Cloud QMS purpose-built for life sciences startups and mid-market companies, including medical device manufacturers. Competes for the same SME medtech customer with quality management and document control — adjacent but overlapping with meddevo's documentation focus.
• AssurX: Quality and regulatory management platform with strong medtech and IVD customer base, offering document control, CAPA, and change management modules. Competes for the same regulatory affairs buyer with overlapping compliance workflows.

Emerging players

• Aras: Open-source PLM platform with regulated industry templates including medical device technical documentation. Competes indirectly by enabling manufacturers to manage product and regulatory data in a unified PLM backbone.

Others

• Metecon: German regulatory consulting and services company for medical devices and IVDs. Recently partnered with meddevo (announced February 2026) and serves the same customer base, but as a services rather than software provider — making them more of a partner than competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/meddevo

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about meddevo