Meddevo eIFU

Meddevo eIFU offers an automated Electronic Instruction for Use (eIFU) platform for medical device manufacturers. Streamline your regulatory documentation and publishing processes with their zero-maintenance solution.

Meddevo eIFU provides a next-generation platform for managing and publishing Electronic Instructions for Use (eIFU), Declarations of Conformity (DoCs), Certificates, and MSDS. Designed for the medtech industry, it automates technical documentation and digitalizes regulatory affairs processes, reducing the regulatory burden by over 50%. Their solution integrates seamlessly with the Meddevo eTD (Technical Documentation) system, enabling automatic publishing of approved documents without manual updates. This zero-maintenance approach ensures compliance and efficiency. The platform offers a user-first experience with a beautifully designed, multi-language public website for end-users, featuring easy navigation, QR code generation, and search capabilities for REF Codes, Name, and UDI-DI. Meddevo eIFU supports full product and multi-language document management with role-based publishing. Launching a compliant eIFU site takes under 5 minutes, requiring no IT intervention. The platform is built on secure, certified servers (ISO 27001/27017/27018/9001) and is pre-validated according to ISO/TR 80002-2, with options for customization and delta validation. They cater to all medical device risk classes and offer a REST API for system integration.

About

**Who they are**
Meddevo eIFU offers an automated Electronic Instruction for Use (eIFU) platform designed for medical device manufacturers. They focus on streamlining regulatory documentation and publishing processes with a zero-maintenance solution.

**Expertise & scope**
* Automated Electronic Instruction for Use (eIFU) platform
* Full product and multi-language document management
* Role-based publishing and QR code generation
* REF Code, Name, and UDI-DI search capabilities for end-users
* Launch compliant eIFU sites quickly with no IT involvement required
* Content management for IFUs, DoCs, Certificates, MSDS, and more
* Tools for Regulatory Affairs (RA) and Quality Assurance (QA) professionals
* Intelligent document creation that self-updates by reusing data from the eTD
* Automated folder structures and submissions management
* Data validation, document freshness monitoring, and submission tracking
* Technical documentation integrated with QM processes for data insight and tracking

**Reputation / proof points**
* Servers certified according to ISO 27001/27017/27018/9001
* Regular penetration and security tests are performed
* Over 40,000 medical devices managed in meddevo eTD

Additional information

The Meddevo platform provides a REST API for integration with other systems. They emphasize that data is stored in open formats, ensuring users retain complete control and ownership. The platform supports multiple languages and offers features like RegulatoryAI and eTD Content Management. Pricing tiers are available, including a free option, with options for Pro and Premium services. Discounts for start-ups may be available upon contact.

Key Highlights

  • Offers an automated Electronic Instruction for Use (eIFU) platform. Source
    “Your Next-Gen Electronic Instruction for Use Platform.”
  • Supports full product and multi-language document management with role-based publishing. Source
    “Full product and multi language document management with roles based publishing, QR code generation.”
  • Enables launching a compliant eIFU site in under 5 minutes with no IT required. Source
    “Launch your fully compliant eIFU site in under 5 minutes. No IT. No waiting.”
  • Servers are certified according to ISO 27001/27017/27018/9001. Source
    “Servers are fully certified according to ISO 27001/27017/27018/9001.”
  • Provides a REST API for connecting to other systems. Source
    “Yes. The meddevo Platform offers a REST API to connect to other systems.”

Certifications & Trust Signals

  • Servers certified according to ISO 27001/27017/27018/9001. Source
    “Servers are fully certified according to ISO 27001/27017/27018/9001.”
  • Regular penetration and security tests are performed. Source
    “Regular Penetration & Security Tests are performed.”
  • Over 40,000 medical devices managed in meddevo eTD. Source
    “40.000+ Medical Devices already managed in meddevo eTD”

Buyer Snapshot

Best for
  • Medical device manufacturers seeking to automate eIFU processes
  • Companies needing multi-language document management
  • Organizations looking to streamline RA/QA workflows
How engagement typically works
  • Self-service platform with API integration options
  • Direct contact for custom solutions and startup discounts
Typical deliverables
  • Electronic Instruction for Use (eIFU) platform
  • Automated document publishing
  • QR code generation
  • Multi-language content management
  • Technical Documentation (eTD) management
Good to know
  • Best when a zero-maintenance, IT-light solution is desired for eIFU deployment.

Pricing

Model: Custom pricing
Public range: Publicly listed: €0 - €1,345
Notes: Publicly listed pricing includes Free, Pro (€495), and Premium (€1,345) tiers. Specific pricing details may vary.
“Pricing: €0; €455; € 1.345; €0; €495”
Languages: English, German, French
Status: listed

Services & Capabilities

eIFU & Implant Card Platform

Pricing model: Custom pricing
Starting from: USD 0
Hosting Model: SaaS
Paper On Request Fulfillment: Not supported
Multilingual Support: Yes
Qr Or UDI Linking: Yes
Validation Pack: Yes
Implant Card Support: Not supported
Compliance Certifications: ISO 27001, ISO 27017, ISO 27018, ISO 9001, ISO/TR 80002-2

Additional eifu_platform Details

Hosting Details
Servers are certified according to ISO 27001/27017/27018/9001. Regular penetration and security tests are performed.
Compliance Certifications
ISO 27001, ISO 27017, ISO 27018, ISO 9001, MDR/IVDR Ready
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