Accomplishments in Regulatory Affairs, Quality Assurance and Clinical Studies

As Qarad's principal consultant, Dirk assisted dozens of IVD and MD manufacturers with European regulations and quality assurance. He helped them with the CE marking of their devices and ISO13485 certification. This includes for example the CE certification of an Asian rapid HIV test, the first of its kind to obtain the CE mark, and many other highly regulated devices. In his consulting activities, Dirk has a pragmatic approach based on his vast experience in areas such as design control, risk management and quality management systems in general.

Consistent with his motivation to find practical solutions for manufacturers, Dirk developed Qarad’s innovative eIFU service for IVD and MD manufacturers.

Between 1994 and 2000, Dirk Stynen founded and extended a new department within Innogenetics N.V. (Belgium), grouping Quality Assurance, Regulatory Affairs, Quality Control, Labeling and Clinical Studies.

During this period, he introduced systems to perform Clinical Studies suitable for product registration, made Innogenetics' labeling multilingual and compliant with European regulations and standards, and achieved Innogenetics' first registrations in major European countries. This included both immunoassays and DNA-based assays for virological markers (HIV, HCV), HLA typing, genetic diseases and bacteriological infections.

Under his management, Innogenetics achieved EN46001 certification and compliance with QSR (21CFR820).

Accomplishments in Academic Research and Diagnostic Assay Development

During his doctoral work at the University of Leuven (Belgium) (1979-1984), Dirk Stynen studied the role of lectins and of other interactions between proteins and polysaccharides in egg formation in insects, using biochemical, immunohistochemical and immunochemical techniques. Work on egg formation, now with a cell biology approach, continued as a postdoctoral fellow (1984-1985) at the University of Pennsylvania (Philadelphia, USA).
At the same university, hands-on experience was gained in a project on the molecular cloning of a T-cell membrane receptor (1986).

Dirk was R&D Manager in the Belgian affiliate of Sanofi Diagnostics Pasteur from December 1986 to 1993. As head of the R&D unit, he specialized in monoclonal antibody production and diagnostic assay development in mycology and bacteriology. His group developed immunoassays for microbiological and fungal markers.

At Innogenetics, he supervised the assay development activities of an ELISA for HIV antigen detection.

Dirk published results of his research and development activities in 36 papers and made oral presentations at ICAAC and other international meetings

QARAD B.V.B.A.

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