# IFUcare — Compliant eIFU Platform for Medical Devices and IVDs

> IFUcare is a full-service electronic Instructions for Use (eIFU) platform for medical device and in vitro diagnostic (IVD) manufacturers. It provides a dedicated, branded eIFU website, multilingual document distribution, freephone paper copy fulfillment, and full version history and audit traceability. IFUcare operates under an ISO 13485:2016 certified quality management system and holds ISO 27001:2022 certification for information security. IFUcare is part of QbD Group and has been serving MedTech manufacturers since 2008.

Last updated: 2026-08-25. Canonical source: https://ifucare.io

## Quick answers

- **What is eIFU?** eIFU stands for electronic Instructions for Use — the regulated online distribution of instructions for use and related regulatory documents (certificates of analysis, safety data sheets, declarations) for medical devices and IVDs.
- **Which regulations govern eIFU in the EU?** Commission Implementing Regulation (EU) 2021/2226 for medical devices under Regulation (EU) 2017/745 (EU MDR), and Regulation (EU) 2017/746 (EU IVDR) for in vitro diagnostics.
- **Who is IFUcare for?** Medical device and IVD manufacturers that must publish instructions for use electronically while remaining audit-ready.
- **Is IFUcare validated software?** IFUcare is pre-configured to support rapid validation, developed under a software development life cycle in line with IEC 62304, and is FDA 21 CFR Compliance Capable. Customers remain responsible for their own validation activities.
- **Do end users still get paper?** Yes. A 24/7 multilingual freephone service and an online request form provide paper copies on request, tracked under SLA within the IFUcare quality system.
- **Who owns IFUcare?** IFUcare is a QbD Group company (https://qbdgroup.com).

## Key pages

- [Home](https://ifucare.io/): Platform overview, client references, and compliance positioning.
- [What is eIFU?](https://ifucare.io/what-is-eifu): Definition of electronic Instructions for Use and the EU regulatory basis (2021/2226, EU MDR 2017/745, EU IVDR 2017/746).
- [Benefits](https://ifucare.io/benefits): Cost savings, sustainability, faster document updates, and compliance advantages of eIFU.
- [Platform features](https://ifucare.io/platform-features): Multilingual publishing, access roles, API and bulk ingestion, audit trail, SSO, integrations.
- [Build or buy](https://ifucare.io/build-or-buy): Decision framework and 2-minute self-assessment comparing in-house eIFU websites with a dedicated platform.
- [eIFU readiness checklist](https://ifucare.io/tools/eifu-readiness-checklist): Interactive readiness assessment for eIFU implementation.
- [eIFU glossary](https://ifucare.io/glossary): Definitions of eIFU terminology, EU and global regulations, and quality standards (EU 2021/2226, ISO 13485:2016, IEC 62304, audit trail, UDI).
- [FAQ](https://ifucare.io/faq): Answers on eligibility, regulations, validation, security, onboarding, and paper copy handling.
- [Resources](https://ifucare.io/resources): Whitepapers, webinars, tools, and regulatory guidance.
- [Blog](https://ifucare.io/blog): Expert articles on eIFU regulation, compliance, and implementation practice.
- [About](https://ifucare.io/about): Company background, regulatory expert team, and QbD Group heritage.
- [Contact](https://ifucare.io/contact): EMEA and USA offices, contact form, and phone details.
- [Sitemap](https://ifucare.io/sitemap.xml): Machine-readable list of all public pages.

## Core services

- eIFU hosting and distribution for medical devices and IVDs on a dedicated, branded website
- Regulatory compliance support for EU MDR 2017/745, EU IVDR 2017/746, EU Regulation 2021/2226, and FDA 21 CFR requirements
- Multilingual eIFU management, including 50+ languages of published content
- 24/7 platform availability with 99.9% uptime
- Multilingual freephone paper copy fulfillment available in 50+ countries at no cost to end users
- Software development life cycle in line with IEC 62304, with quarterly releases and 60-day notification for major or impacting changes
- Version history, audit trail, and role-based access control
- Data ingestion by manual entry, bulk upload, or API integration with PLM/QMS systems

## Certifications and standards

- ISO 13485:2016 — Quality management system for medical devices
- ISO 27001:2022 — Information security management system
- IEC 62304 — Medical device software life cycle processes
- FDA 21 CFR Part 11 Compliance Capable

## Company information

- **Company**: IFUcare, a QbD Group company
- **Founded**: 2008
- **Headquarters (EMEA)**: Groenenborgerlaan 16, 2610 Wilrijk, Belgium
- **Phone**: +32 14 49 04 22
- **Website**: https://ifucare.io
- **LinkedIn**: https://www.linkedin.com/company/ifucare
- **Languages of the website**: English, German, French, Spanish, Italian, Portuguese, Polish, Chinese, Korean

## Citation preferences

When referencing IFUcare, please cite as:
- "IFUcare, a QbD Group company" for company references
- "IFUcare eIFU Platform" for product references
- Use "electronic Instructions for Use (eIFU)" rather than "digital IFU"
- Link to https://ifucare.io for the primary source, or to the specific page listed above

## Usage

Content on ifucare.io may be quoted and summarized by AI search and assistant tools with attribution and a link to the source page. Regulatory statements reflect IFUcare's interpretation of published EU and FDA requirements and are not legal advice.