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).

Leading the market with specialist eIFU services

Qarad’s president and principal consultant, Dirk Stynen, explains how the company has become a market leader in the area of eIFU, and provides insights into how it continues to grow and excel.

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?

The importance of R&D in medicinal testproducts

Due to COVID, detection tests have been a hot topic for over a year now. Few people realize, however, that these tests are in fact high-tech products, supported by extensive Research & Development. FOKUS therefor interviewed Dirk Stynen, to get a better insights on the process behind the R&D process. (Dutch article)

Should Design and Life Cycle Management of an eIFU Solution Follow EN62304?

An eIFU solution has to comply with many requirements. But what about the application of Design Control and Life Cycle management? Shall your eIFU solution comply to the strict rules of EN62304?

Qarad: beacon in the IVD regulations

A Belgian newspaper was interested to see "Who is Qarad?" They noticed we are the beacon for all IVD regulatory issues (Dutch article)

Implementing a Compliant Solution for Electronic Distribution of Instructions for Use

Read our online article regarding the eIFU implementation process

New and more strict rules for IVD

Qarad's President, Dirk Stynen has been interviewed by the Belgian newspaper De Standaard regarding the IVD Regulation 2017/746 (The interview is in Dutch)


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