Blogs

The Qarad touch: How a commitment to customer support spells success for IVD and medical device customers

The information in instructions for use (IFU) for medical devices and in vitro diagnostics (IVD) is both highly regulated and fundamental to patient safety. For manufacturers of medical devices and IVDs, it is essential to know they can rely on their service providers. Thanks to Qarad’s deep expertise in IVDs and medical devices and its long experience in regulatory affairs, its service stands out from the rest.

Qarad integrates EU’s Implementing Regulation 2021/2226 on eIFU for medical devices

The European Commission has made changes to rules governing the provision of electronic instructions for use (eIFUs) for medical devices (MDs), as originally laid down in Regulation 207/2012. Qarad immediately applied the new EU provisions to their services and informed every customer of this change.

The added value of Qarad’s multilingual freephone service to their eIFU solution

Government regulations for MD and IVD products allow manufacturers to provide IFUs digitally in the form of portable electronic storage media (e.g. CD or USB) or via the company’s website. Although these digital IFUs are allowed, the manufacturers are still obliged to provide an alternative means so clients can obtain paper copies on request. Qarad’s free telephone service guarantees quick and efficient handling of these requests without any burden to the manufacturer.

The Impact of Implementing an eIFU Solution on Your Quality Management System

In Europe, manufacturers of certain categories of medical devices (MD), such as implantable MD, and of in vitro diagnostic (IVD) devices for professional laboratory use, can replace the paper instructions for use (IFU) with an electronic version (eIFU). For MD the conditions and requirements have been published in Regulation 207/2012. For IVD, a guidance document was published as MEDDEV 2.14/3 (2017).

Breaking: Qarad Joins the QbD group!

We are proud to announce that Qarad is now a part of the QbD Group. Joining forces with Quality by Design is a big new step in our own 21-year history. By combining forces within the QbD group, we will be able to assist clients in the full ‘from idea to patient’ life cycle even better.

What do Notified Bodies expect of your eIFU solution and its implementation?

Implementing an eIFU solution in your company has major implications on your QMS. Notified Bodies will review how you handled the process. This article explainswhat you can expect.

Regulatory focus: Impact of the latest rules for European IVD device manufacturers

Dirk Stynen, Qarad's founder and President, was interviewed about the impact of the new IVDR on the field.

EIFU versus paper-based IFU: What are the benefits of going digital for manufacturers?

Qarad is pioneer and market leader in the eIFU world. But why do more and more manufacturers chose to move to eIFU?

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