What are eIFU?
Distribute your documents online on a pre-validated website
eIFU stands for “electronic instructions for use“, but the term encompasses more than just these documents. It also includes the online distribution of other regulatory documents, such as certificates of analysis, safety data sheets, and quality control documents.
eIFU can be made available via a manufacturer’s website but due to the strict regulations, these websites must be validated for compliance. IFUcare removes this burden and offers a pre-validated website, still matching your corporate identity. Moreover, maintenance and continued compliance are ensured.
Why choose eIFU over paper?
Make changes faster
If changes need to be made, it takes time to recall the product, replace the paper IFU and redistribute the product. With electronic IFUs, updates can be made in minutes, reducing the likelihood of a product recall.
Reduce risk
Providing eIFUs with better readability and ensuring that documents are always available reduces the risk of errors and improves patient safety.
Save paper and costs
Switching to eIFU is better for the environment and saves your company the cost of printing and managing documents. It also reduces packaging and shipping costs.
Simplify your process
We make your eIFU easy to access and keep track of all version changes. We believe that technology should make your and your customers’ lives easier.
Improve readability
You have more options for displaying the information in your eIFU – they can be in larger font, and can include colours and images to make them easier to understand.
Benefits of IFUcare
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Easy to use
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Smooth to implement
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Off-the-shelf solution
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Highly configurable user interface
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Intelligent search functions
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Support from our regulatory experts
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Personal training on use of the IFUcare platform
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Customer support by phone or email
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Familiar to Notified Bodies
Reduce risk
Our eIFU hosting platform is validated and compliant with regulations, so Notified Bodies will be more willing to accept. We also take care of automatically recording changes to your documents or the website, and our broad language support makes it easier for end users to find the correct documents.
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Compliant and up-to-date with EU and FDA regulations
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Validated system
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Analytics and reporting available
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FDA 21CFR part 11 compliant, allowing full traceability
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Supports 55 languages
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An ISO 13485 and ISO 27001 certified supplier
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Save on paper
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Save on associated costs
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Make changes faster
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Sustainable solution
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Questions about the system
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Interpretation of your business needs and how to convert them to the system
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Clarification on unanswered questions in Notified Body audit
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Training
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Ongoing support
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Main features of IFUcare
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 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!
CONTACT US
ISO 13485 and ISO 27001 certified
Pas 257, 2440 Geel BELGIUM
+32 (0)14 49 04 22
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