Expert Team
In-house regulatory, quality, support & development specialists
In-house Regulatory Experts
ISO 13485 & 27001 Certified
Validated off the shelve
Full-Service eIFU Solution.Powered by Regulatory Experts.
Regulatory requirements, integration and validation are at the core of IFUcare's design.
Full Validation
End-to-end validation built into the platform
Proven Acceptance
No regulatory surprises or hiccups
https://eifu.example.com
Trusted by 50%+ of the Top 30 MedTech Companies
Leading medical device manufacturers rely on IFUcare
About IFUcare
Have your eIFUs online in no time
with IFUcare's SaaS platform backed by regulatory experts and a full-service compliance team
IFUcare enables medical device (MD) and in vitro diagnostic (IVD) manufacturers to leave paper instructions for use (IFU) out of product packaging and make them accessible online.
IFUcare is a service of QbD Group, the regulatory experts specializing in MDs and IVDs. As a pioneer in offering electronic IFU (eIFU) services, we have successfully tackled many of the challenges in implementation such as dealing with changes in regulations and perfecting the validation process to fulfill Notified Body expectations.
Our Team
Regulatory Expertise Built In
Our dedicated team of 50+ regulatory and quality specialists ensures your eIFU solution meets every requirement. Here are some of the experts leading your success.
Dimitri Jordens
eIFU Services and Information Security Manager
10+ years at IFUcare, background in biochemistry & biotechnology
Kirsten Van Garsse
Dir. Authorised Representative Services & Manager IVD
20 years of experience in the IVD field
0+
Years Experience
Regulatory expertise since 2008
0+
Products Hosted
Trusted by manufacturers worldwide
0+
Monthly Downloads
eIFUs accessed every month
0+
Languages
Global multilingual support
Platform Features
Everything You Need for eIFU Compliance
A complete solution designed to meet the EU, US and all other international eIFU regulations.
Dedicated Website for Your eIFU
A fully branded, regulation-compliant eIFU website configured to your needs — hosted, maintained, and monitored by IFUcare.
Country-Specific Availability
Control which documents are available in which countries. Configure distinct groups of IFUs per market to meet local regulatory requirements.
Document Management
Upload, version, and archive IFUs, certificates, SDS, and quality documents with full audit traceability.
Multilingual and Global
60+ languages, all countries supported.
Intelligent Search
Fully configurable search experience — define which attributes, filters, and fields are searchable so end users always find the right document quickly.
Subscription Module
As a manufacturer, you are required to notify customers who have previously downloaded an IFU in the event of an update. Our platform includes an automated system to handle these notifications. No more manual interactions required!
Restricted Access
Struggling with distributing public and confidential documentation to different audiences (HCPs, patients, distributors)? Our platform gives you full control to limit and customize access through personal access accounts.
Audit Logging
Comprehensive audit trails for all actions, exportable reports for regulatory inspections and quality audits.
Multilingual Freephone Service
Regulations require that paper copies can be provided upon request, free of charge. Our worldwide call center is available 24/7 and takes the burden out of your hands.
Analytics & Reporting
Track downloads, search patterns, geographic usage, and system performance with detailed dashboards.
PLM/DMS Integration
Built API-first for seamless integration with your existing PLM, DMS, and enterprise systems.
Third-Party Penetration Testing
Our platform undergoes regular independent penetration testing to proactively identify and resolve vulnerabilities — ensuring your eIFU data stays protected.
GDPR Compliance
Full compliance with EU data protection regulations. Personal data is processed lawfully, stored securely, and handled transparently with clear privacy controls.
Full-Service Support
Services – Supporting Your eIFU Journey
Digitalizing your Instructions for Use is more than a technical step. Compliance, validation, and user experience are critical to ensure your eIFU journey is successful.
IFUcare combines a proven SaaS platform with expert services, helping manufacturers meet regulatory requirements and reduce risks.
Implementation & Validation Support
Step-by-step onboarding tailored to your product portfolio.
- Full validation package ensuring regulatory compliance
- Guidance on setup, data migration, and system qualification
Regulatory & Quality Expertise
Backed by QbD Group's regulatory and quality specialists.
- Advice on labeling, IFU requirements, and audit readiness
- Integration with your Quality Management System (QMS)
Multilingual Freephone Service
24/7 freephone service for paper copy requests by healthcare professionals and patients.
- Support in multiple languages, ensuring accessibility across regions
- Reduces risk of non-compliance and strengthens user trust
Ongoing Compliance & Updates
Your eIFU system aligned with current regulations.
- Continuous monitoring of regulatory changes and industry standards
- Optional audit and training services
Compliance-by-Design
Built for Regulatory Excellence
Every feature is designed with regulatory requirements in mind, making your compliance journey smoother and audit-ready.
IEC 62304
Software Lifecycle
21 CFR Part 11
Electronic Records
EU MDR 2017/745EU IVDR 2017/746EU 207/2012EU 2021/2226 Amdt. 2025/1234MEDDEV. 2.14/3 rev.1EU 2016/679 (GDPR)IEC 62304:2006FDA 21 CFR §352FDA 21 CFR Part 11MDUFMA §206Canadian MD/IVD GuidanceBrazilian RDC No. 830Brazilian RDC No. 751Australian eIFU RegulationUK MDR Reg. 4JMDSAPISO 13485ISO 27001ISO 14971UKCA
Unique to IFUcare
24/7 Multilingual Freephone Support
When healthcare professionals need a paper copy, they call us directly — not your team. We handle fulfillment in their language, any time of day, at no extra cost.
Global
Coverage
24/7
Always available
Free
No extra cost
✕Competitors typically offer email-only support during business hours
Customer Stories
Trusted by Leading MedTech Companies
See why manufacturers worldwide choose IFUcare for their eIFU needs
"IFUcare has been very helpful in our recent transition from paper to electronic instructions for use. They offer a very professional eIFU service and platform. Changing to eIFU doesn't only save us cost but it's also very efficient. And of course it is good for the environment. Every company should basically be doing this. Apart from being very client focused and flexible, the IFUcare team has excellent and up to date regulatory knowledge."
Peter Kievit
Senior Quality Manager
Leading IVD Manufacturer
Ready to go electronic?
Book a short demo to see how our platform and services can accelerate your eIFU journey.
✓Trusted by 200+ clients worldwide
✓Built by medical device and IVD experts
✓Designed to save time, costs, and reduce compliance risks
50%+
Top 30 MedTech
500,000+
Products Hosted
19+
Years Experience
60+
Languages Supported
Resources
Latest Insights & Guides
Expert knowledge on eIFU compliance, regulations, and digital transformation
