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Your full-service eIFU 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 easy-to-use website paired with the support of our expert 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.

We are ISO 13485 and ISO 27001 certified.

Our IFUcare 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!

Why use electronic instructions for use instead of paper?

An open laptop, with the IFUcare client portal on the screen
  • Save paper and costs
  • Eliminate limitations of printing
  • Reduce risk
  • 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.

Explore our whitepapers

CONTACT US

ISO 13485 and ISO 27001 certified
Pas 257, 2440 Geel BELGIUM
+32 (0)14 49 04 22

Ⓒ2022 QARAD. All right reserved

IFUcare and Qarad are part of the