AI TOOL PROFILE
meddevo | Medical Device Regulatory Compliance Software
- Healthcare
- Compliance Management
- Medical device manufacturers
- IVD manufacturers
- Regulatory affairs teams
Pricing
Pricing includes a free tier for eIFU, a Pro plan starting at 455 EUR/month (billed annually), and a Premium plan at 1345 EUR/month (billed annually).
At a glance
- Best for
- Medical device manufacturers, IVD manufacturers, Regulatory affairs teams
- Key use cases
- Managing Technical Documentation, Digital IFU Distribution, Country Registration Preparation, Regulatory Content Digitization
- Integrations
- MS Word, MS Excel, REST API
- Official website
- Visit meddevo official website
How AI is used
meddevo is a regulatory technology platform for medical device and IVD manufacturers. Instead of managing static files, the software uses a structured data model to connect products, components, and standards, which supports the generation of technical documentation and registration dossiers.
The platform is designed for companies scaling their portfolios across different markets. It provides tools for electronic technical documentation (eTD) and electronic instructions for use (eIFU), and includes a RegulatoryAI assistant to support medical writing and the digitization of legacy documents.
Buyers should note that the platform's capabilities are based on its content-first data model, which differs from traditional file storage. Users should confirm which plan fits their document volume and user count requirements.
Key Features
Electronic Technical Documentation (eTD)
A structured data model that supports automated document generation and impact analysis of changes.
Electronic Instructions for Use (eIFU)
A platform to manage and publish multilingual IFUs with QR code generation and custom branding.
RegulatoryAI
An AI assistant designed to help draft technical content and extract data from legacy documents.
eSubmissions
Tools designed to automate the creation of registration TechFiles using country-specific templates.
GSPR Management
Support for managing General Safety and Performance Requirements.
Risk and Clinical Documentation
Features that support ISO 14971 risk management and Clinical Evaluation Report (CER) documentation.
Use Cases
Managing Technical Documentation
Using a structured data model to create and maintain electronic technical documentation for medical devices.
Digital IFU Distribution
Publishing and managing electronic instructions for use via a compliant public website.
Country Registration Preparation
Using automated templates to curate registration TechFiles for specific target countries.
Regulatory Content Digitization
Using AI to transform legacy documents into structured, searchable regulatory data.
Integrations
- MS Word
- MS Excel
- REST API
FAQ
What is meddevo eTD?
- meddevo eTD is a platform that replaces traditional document-based technical documentation with a structured regulatory data model to support automated document generation.
Does meddevo offer a free version?
- Yes, meddevo offers a free tier for its eIFU platform, which includes a multilingual website and support for up to 5 documents.
Is the software compliant with regulatory standards?
- The platform is hosted in Germany, is GDPR compliant, ISO 27001 certified, and supports 21 CFR Part 11.
Source category: Healthcare
Source subcategory: Compliance Management
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