Blogs

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?

Addressing the strict rules for IVD manufacturers

La Libre Belgique interviewed Dirk Stynen regarding the new regulations for IVD and how Qarad continues to fulfil the manufacturers needs.

Brexit and the Impact on the IVD and MD Industries

The United Kingdom (UK) leaves the European Union (EU) on January 1, 2021. Manufacturers wanting to begin or continue business within the UK need to understand the implications of this move and should start making preparations today.

Qarad opens new company in UK

The United Kingdom leaves the European Union on January 1, 2021. As regulatory experts, Qarad is ready to assist the Medical Devices and In Vitro Diagnostic industry through this change. With the establishment of Qarad UK Ltd., the fourth Qarad office, Qarad can now also function as UK Responsible person.

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)

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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