IFUcare goes beyond eIFU hosting

Discover the benefits of going digital

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.

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Benefits of IFUcare

  • Easy to use
  • Smooth to implement
  • Off-the-shelf solution
  • Highly configurable user interface
  • Intelligent search functions
  • Support from our regulatory experts
  • Personal training on use of the IFUcare platform
  • Customer support by phone or email
  • Familiar to Notified Bodies

Save time

We’ve made our IFUcare platform user-friendly so you can get your eIFU online quickly and easily. If you do have questions, we are available to help you.

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.

  • Compliant and up-to-date with EU and FDA regulations
  • Validated system
  • Analytics and reporting available
  • FDA 21CFR part 11 compliant, allowing full traceability
  • Supports 55 languages
  • An ISO 13485 and ISO 27001 certified supplier
  • Save on paper
  • Save on associated costs
  • Make changes faster
  • Sustainable solution

Save costs

In addition to the significant cost saved from switching from paper to electronic IFU, the IFUcare platform can cater to both health professionals and patients, allowing documents to be stored in a single rather than multiple locations.

Enjoy the support

IFUcare’s team consists of a broad expertise (developers, project managers, support…). Thanks to their thorough knowledge of the system and all applicable regulations, you can count on them for all your questions.

  • Questions about the system
  • Interpretation of your business needs and how to convert them to the system
  • Clarification on unanswered questions in Notified Body audit
  • Training
  • Ongoing support
  • ...

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.

CONTACT US

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

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