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.
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 Qarad (part of the 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 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.
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.
Integration and validation of your processes is in IFUcare’s DNA. We ensure the regulatory acceptance of your eIFU solution with no hiccups.
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.
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!