09 / 09 / 2021 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). Read more »
22 / 07 / 2021 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. Read more »
16 / 06 / 2021 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. Read more »
16 / 06 / 2021 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. Read more »
11 / 05 / 2021 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? Read more »
30 / 03 / 2021 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) Read more »
18 / 03 / 2021 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? Read more »
17 / 09 / 2020 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) Download »
06 / 07 / 2020 Implementing a Compliant Solution for Electronic Distribution of Instructions for Use Read our online article regarding the eIFU implementation process Read more »
25 / 03 / 2020 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) Read more »
