E-labeling / eIFU
Are you looking for eIFU services? Qarad – part of the QbD Group – can support in vitro diagnostics (IVD) and/or medical device manufacturers to leave paper Instructions for Use (IFU) out of their product packaging and make them accessible to the end user on the Internet.
Find out more about our eIFU service below.
Part of QbD Group
This service is supported by Qarad
What is E-labeling / eIFU
Save paper & costs
How much does your company spend on packaging, paper, printing, and logistics? A lot! Enough to consider an eIFU service…?
Simplify your process
Complex processes take a lot of time and effort. However, companies are often too busy to improve their processes. Our online platform can help you simplify them.
Differentiate your customer experience
Our technology can make your life and your clients’ lives easier. By making your documents available on our portal, they become easily retrievable and version-controlled.
Reduce risk
Reduce your liability and the likelihood of having to recall products related to your IFU. Our solution is well-known to notified bodies. The acceptance of your eIFU will be facilitated by Qarad’s integration and validation of your approach.
Comply with regulations
Online document libraries are easy in an unregulated industry. However, compliance with EU, FDA, and other regulations are much more complex. Our services meet all regulatory requirements and thus make a difference.
Why QbD Group?
As a pioneer, Qarad – part of the QbD Group – has been offering the eIFU service since 2008. Therefore, we have already addressed many of the risks.
This means you are covered by a single vendor solution, developed by regulatory experts with a focus on compliance and risk management.
Qarad’s eIFU services comply with all EU, FDA, and national requirements regarding the e-service itself, its development and validation, and the supplier. Therefore, our eIFU service is your regulatory assurance.
Discover all the benefits of our service below:
- 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 and ISO27001 certified supplier
- Software development according to EN62304
- A multilingual website interface and multilingual worldwide free phone service
- A smooth implementation process taking a minimum of your time
- An off-the-shelf solution with a fully configurable user interface
Dedicated website
Based on your preferences, we offer a configurable standard platform.
Integration and validation of your processes are in Qarad’s DNA. We ensure the smooth implementation and regulatory acceptance of your eIFU solution.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.
