IFUcare

Does your organization struggle with the challenges of paper-based Instructions for Use (IFU)? From high printing and logistics costs to complex compliance requirements, traditional IFUs can be a costly and time-consuming hurdle for in vitro diagnostics (IVD) and medical device manufacturers.

IFUcare understands your need for a more efficient, cost-effective, and compliant solution. That’s why we offer a seamless eIFU service, empowering you to leave paper IFUs behind and transition to electronic labeling.

Visit the IFUcare website

IFUcare helps manufacturers to distribute their technical documentation via a digital platform. We offer a single supplier solution, developed by regulatory experts with a focus on compliance and risk management.

With user-friendly navigation and robust features, IFUcare enables you to reduce costs, ensure compliance, and deliver a superior user experience. Our customizable, multilingual interface ensures accessibility for global users while meeting strict regulatory standards.

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Save paper & costs

How much does your company spend on packaging, paper, printing, and logistics? A lot! Enough to consider an eIFU service…?

Simplify your process

Complex processes take a lot of time and effort. However, companies are often too busy to improve their processes. Our online platform can help you simplify them.

Differentiate your CX

Our technology can make your life and your clients’ lives easier. By making your documents available on our portal, they become easily retrievable and version-controlled.

Reduce risk

Reduce your liability and the likelihood of having to recall products related to your IFU. Our solution is well-known to notified bodies. The acceptance of your eIFU will be facilitated by QbD's integration and validation of your approach.

Comply with regulations

Online document libraries are easy in an unregulated industry. However, compliance with EU, FDA, and other regulations are much more complex. Our services meet all regulatory requirements and thus make a difference.

How do we do it?

Based on your preferences, we offer a configurable standard platform. Integration and validation of your processes are in our DNA. We ensure the smooth implementation and regulatory acceptance of your eIFU solution.

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Why partner with QbD Group?

We have been a pioneer in eIFU services since 2008, addressing regulatory risks with a single-vendor solution developed by regulatory experts focused on compliance and risk management.

Our eIFU services meet EU, FDA, and national requirements, ensuring your regulatory assurance. Key benefits include:

Developed by regulatory experts with a focus on compliance and risk management.
Fully compliant with EU and FDA regulations (MEDDEV 2.14/3 for IVD and Commission Regulation (EU) No. 207/2012 on MD).
Full traceability with logs of all user and administrator actions (21CFR11 compliant).
Familiar concept to notified bodies
ISO13485 and ISO27001 certified supplier.
Software development according to IEC80002.
Multilingual interface and worldwide multilingual support.
Smooth, time-efficient implementation.
Fully configurable user interface for an off-the-shelf solution.

White Implants

Qarad 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 costs 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 Qarad team has excellent and up to date regulatory knowledge.

Peter Kievit

General Manager, White Implants

Get in touch

Based on your preferences, we offer a configurable standard platform.

Integration and validation of your processes are in our DNA. We ensure the smooth implementation and regulatory acceptance of your eIFU solution.

Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.