The regulatory data backbone for medtech
Join the eTD user community
Regulatory complexity is growing. Your tools are not.
Medical device regulation evolves constantly.
Your documentation does not.
Most manufacturers still manage regulatory work in static documents, disconnected systems and manual workflows. Every change triggers weeks of impact analysis, document updates and cross checks.
The result:
- Slow submissions
- High audit pressure
- Limited transparency across products
- No real scalability for growing portfolios
Built on regulatory data, not documents
meddevo starts where others stop.
At structured regulatory content.
Instead of managing documents as isolated files, meddevo introduces a content based regulatory data model that connects products, components, claims, standards, ... ... ... in one system.
This enables:
- Live impact analysis before changes
- Continuous completeness monitoring
- Automated document generation and updates
- Full traceability across regulatory frameworks
Your documentation becomes a living system, not a static archive.
One platform. Multiple solutions. Fully connected.
meddevo is a suite of independent solutions that unfold their full power when connected through the eTD data model. Start with one app or build a complete regulatory operating system.
meddevo eTD
Your regulatory backbone
eIFU
eStandards
Document Writer
GSPR Manager
Submissions
Multilingual Content Management
Approval Workflows
Document Management
SOP Management
CAPA & Changes
Clinical Evaluation
Collaborations
Document Hub
RegAI
Risk Management
eDesign
SoonAll solutions share one source of truth. No redundancies. No broken links.
meddevo eTD
Content based technical documentation at scale
meddevo eTD is a regulatory platform designed for manufacturers managing complex portfolios across multiple markets.
With eTD you can:
- Build technical documentation based on structured regulatory data
- Automatically generate and maintain documents
- Monitor completeness across MDR, IVDR and global frameworks
- Create submissions from validated snapshots
- Manage global variations without redundancy
From day one, eTD is audit ready, enterprise grade and built for growth.
meddevo eIFU
Digital instructions for use with global reach
meddevo eIFU is a complete electronic instructions for use platform that simplifies document management and ensures regulatory compliance across all your markets.
With eIFU you can:
- Multi-language IFU management with automated publishing
- Full compliance with EU 2021/2226 and MDR/IVDR
- QR code generation for seamless product integration
- Public website hosting with custom domain support
- Version control and audit trail for all documents
Start free and scale as you grow. No setup fees, no hidden costs.
meddevo RegulatoryAI
Your Regulatory Affairs Assistant built for medtech
Digitalizes your technical documentation and helps with medical writing. RegulatoryAI combines the power of large language models with your company-specific regulatory knowledge for accurate, compliant content generation.
Document Digitalization
Transform legacy documents into structured, searchable regulatory data
Medical Writing Assistant
Draft technical content with AI trained on regulatory requirements
Regulatory Q&ASoon
Get instant answers from your own documentation and standards
Compliance GuidanceSoon
Navigate MDR, IVDR and global frameworks with expert AI support
Regulatory Intelligence
Please help me with this part
Writing your MDR classification justification...
Document Data Extraction
Device Name
CardioMonitor Pro
Classification
Class IIa
Intended Use
Cardiac monitoring
Manufacturer
MedTech GmbH
Secure by Default
Enterprise ready by design
meddevo is built for regulated environments and enterprise requirements.
- EU data residency
- Full audit trail and approval workflows
- SSO and access control
- Validated according to ISO/TR 80002-2
- Compliance center access
You gain speed without sacrificing control.
Built for what comes next
Regulation will continue to evolve.
Your systems should be ready.
meddevo is continuously expanding its app ecosystem with AI agents, new regulatory modules and open integrations via REST API. All powered by one structured data model.
You are not buying a tool.
You are building a foundation.
Continuously Evolving
Your path to digital regulatory operations
Start your evaluation
Explore use cases and demos
Talk to regulatory experts
Get personalized guidance for your needs
Go live with confidence
Expert support throughout onboarding
No pressure. No blind trials. Just clarity, expertise and a guided path forward.
Trusted by regulatory teams across Europe
See why medical device companies choose meddevo for their regulatory workflows.
“A great team where regulatory expertise and technical background go hand in hand!”
PHS Medical
Regulatory Affairs
“The meddevo software effectively supports us in implementing the MDR, especially given our broad product range.”
Wagner Polymertechnik
Technical Documentation and Regulatory Affairs
“We have finally found a solution that is flexible and can be tailored precisely to our needs.”
Henry Schein
Regulatory Affairs HQ
“meddevo eTD simplifies the creation and maintenance of technical documentation with an intuitive, MDR-compliant structure. With automated workflows and clear traceability, eTD provides efficient support for international submissions. A reliable tool for regulatory affairs that saves time and ensures compliance.”
Löwenstein Medical
Regulatory and Clinical Affairs
“Thanks to meddevo, we were able to manage our technical documentation efficiently. I can recommend meddevo to anyone working in the medical device industry who is looking for a reliable and up-to-date eTD platform.”
Windstar Medical
Technical Documentation
“A great team where regulatory expertise and technical background go hand in hand!”
PHS Medical
Regulatory Affairs
“The meddevo software effectively supports us in implementing the MDR, especially given our broad product range.”
Wagner Polymertechnik
Technical Documentation and Regulatory Affairs
“We have finally found a solution that is flexible and can be tailored precisely to our needs.”
Henry Schein
Regulatory Affairs HQ
“meddevo eTD simplifies the creation and maintenance of technical documentation with an intuitive, MDR-compliant structure. With automated workflows and clear traceability, eTD provides efficient support for international submissions. A reliable tool for regulatory affairs that saves time and ensures compliance.”
Löwenstein Medical
Regulatory and Clinical Affairs
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Ready to Transform Your Technical Documentation?
Join over 130.000 medical devices already managed in meddevo to streamline your regulatory workflow.
- Free personalized demo
- Start with your existing docs
- Expert onboarding support