Why eIFU and E-Labeling is good for you

Simplify your process

Complexity eats a lot of time and effort.

Paradoxically, we are often too busy to improve.
Simplify and take full advantage of the new possibilities that come with our online platform.

Differentiate with customer experience

Get the paper out of the lab. Make your documents available on our portal. Easy to find and version controlled.

Because we believe that technology should make your life and your clients’ lives much easier.

Save paper and costs

What does your company spend on packaging, paper, printing, logistics and the management of all that?
Start counting because those areas will fuel an easy initial business case for eIFU with Qarad.

Reduce risk

Decrease your liabilities and the chances of product recall related to your IFU.
Qarad’s solution is familiar to Notified Bodies. Your eIFU acceptance will be facilitated by Qarad’s integration and validation of your approach.

Comply with regulations

Online document libraries are easy in a non-regulated industry. However, compliance with EU, FDA and other counties’ regulations is playing in a different league.

Qarad’s services meet all the regulatory requirements and that makes the difference.

Schedule a demo with one of our E-Labeling/eIFU experts!

Get to know our E-Labeling and eIFU solution via a personalized demo.

Our experts will demonstrate how user-friendly our website is for you to upload the labels and IFUs and for your customers to download your documents .

Qarad's solution

Risks under control

Qarad is offering eIFU since 2008, as the pioneer. We have had the time to tackle a vast part of the risks.

So, you are covered by

• a single supplier solution
• developed by regulatory experts
• with a focus on compliance and risk management.
  
  

Rest assured

Qarad’s E-Labeling and eIFU services meet all the EU, FDA and national requirements with respect to

• the e-service itself
• its development and validation 
• its supplier

By meeting all those requirements, you can sleep soundly. Qarad’s E-Labeling and eIFU service is your regulatory assurance.

What customers say

“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 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 Qarad team has excellent and up to date regulatory knowledge.”

Peter Kievit,
General Manager White Implants

Your benefits

• Developed by regulatory experts focusing on compliance and risk management.
• A solution fully compliant with EU and FDA regulations
  (MEDDEV 2.14/3 for IVD and Commission Regulation (EU) No. 207/2012  on MD).
• Logs all user and administrator actions and all end-user downloads, allowing full traceability, 21CFR11 compliant.
• A concept familiar to notified bodies.
• An ISO13485 certified supplier and software development according to EN62304.
• A multilingual website interface and multilingual worldwide Freephone service.
• A smooth implementation process taking a minimum of your time, thanks to the use of existing technology.  
• From an off-the-shelf solution with configurable user interface to a fully tailor-made platform.
  
  

You get more than a website

1) Dedicated website

Based on your preferences, we offer either a configurable standard platform or a tailor-made solution.

2) Multilingual Freephone Service

As required by EU Regulations, there is a need for a back-up system. Therefore, we have a worldwide call center, available 24/7, to handle your customers eIFU requests.

3) Implementation and regulatory acceptance

A less visible, but certainly essential part. Integration and validation of your processes is in Qarad’s DNA. We ensure the smooth implementation and regulatory acceptance of your E-Labeling solution.

Standard or tailor-made

Qarad’s E-Labeling / eIFU services come standard on a configurable platform or as a tailor-made solution to welcome your specific or extra needs. Both solutions are familiar to the Notified Bodies.

Standard

• Ready to use, no development required
• Landing page can be customised
• Fast and user-friendly set up
• Continuous improvements, immediately available after release
• Validated state guaranteed, all validation documentation available

Tailor-made

• Look and feel and end-user experience adapted to your corporate identity
• Landing page and database per Business Unit, Division…
• Development based on individual requirements
• Integration possible with other applications