Full-Service eIFU Medical Solution
E-labeling created by regulatory experts in MD & IVD
Want to reduce risk and save time & money in a compliant way?
Host your instructions for use on our validated platform.
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 IVD | Qarad, 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 eIFU Medical Solution
Dedicated website
for your eIFU
Our platform is EU/FDA regulation compliant and can be configured to suit your needs. Distinct groups of documents can be made available for different countries.
Multilingual
freephone service
Regulations require that paper copies of your documents can be provided free of charge upon request. Our worldwide call center is available 24/7 and takes the burden out of your hands.
Implementation support
and regulatory acceptance
Integration and validation of your processes is in IFUcare’s DNA. We ensure the regulatory acceptance of your eIFU solution with no hiccups.
Restricted access
Struggling with distributing your public and confidential product documentation to different audiences (e.g. HCPs, patients, distributors, etc.)? Our platform gives you full control to limit and customize access to individual documentation through personal access accounts.
Subscription module
As a manufacturer, you are required to notify customers who have previously downloaded an IFU on your website in the event of an update. Our platform includes an automated system to handle these notifications. No more manual interactions required!
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 (MDR/IVDR).
- 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 Hotline
- 24/7 access to IFUs for healthcare professionals and patients.
- Support in multiple languages, ensuring accessibility across regions.
- Reduces risk of non-compliance and strengthens user trust.
Subscription & Access Management
- Controlled, restricted access to technical documentation.
- Configurable subscription model to fit your distribution strategy.
- Secure access logs for full traceability.
Ongoing Compliance
& Updates
- Periodic reviews to keep your system aligned with new regulations.
- Continuous monitoring of regulatory changes and industry standards.
- Optional audit and training services.
Ready to go digital?
Book a short demo to see how our platform and services can accelerate your eIFU journey.
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Trusted by 200+ clients worldwide.
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Built by medical device and IVD experts.
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Designed to save time, costs, and reduce compliance risks.
Why use electronic instructions for use instead of paper?
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Save paper and costs
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Eliminate limitations of printing
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Reduce risk
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Make changes faster
Don’t just take it from us, here’s what our customers say
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.
Connecting Healthcare Globally
At IFUcare, our commitment to excellence knows no borders. We are proud to support healthcare providers in various regions around the world. Explore our global footprint and discover how we partner with clients across continents.
eIFU Map
Explore our whitepapers
CONTACT US
ISO 13485 and ISO 27001 certified
Pas 257, 2440 Geel BELGIUM
+32 (0)14 49 04 22
FAQ
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IFUcare is a brand name of Qarad
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