Qarad brings 35 years of expertise in Regulatory Affairs and Quality Assurance regarding In Vitro Diagnostic Devices – which is regulated by the specific IVD Regulation (IVDR) – to the group. Its activities consist of consultancy and other services regarding CE Marking and Quality Systems and Electronic Instructions for Use. eIFU is an E-labeling solution which allows manufacturers to offer users online instruction manuals of their devices. This way, eIFU not only adds simplicity and cost-efficiency to the process, but also makes the end result more client friendly and fully compliant.
Match in expertise and DNA
“QbD has been focusing on the Medical Devices industry for many years now,” says CEO Bart Van Acker. “Thanks to Qarad, we now also cover the IVD niche, which was still relatively uncharted terrain for QbD. With the expansion of our service offering and IVD expertise, we’re boosting our international reputation as the number 1 partner for clients that need guidance in the full ‘from idea to patient’ life cycle of their Medical Device. And in consistency with all our growth endeavors so far, we haven’t based our choice solely on the quality and complementarity of Qarad, but also on a DNA match. The values that Qarad holds dear show a big overlap with our own JPEG-values: the perfect foundation to kick off a true win-win partnership.”
Dirk Stynen, founder of Qarad, adds: “We fully share Bart’s enthusiasm. When we first met, Bart and I immediately clicked, and we felt that now was the right time for both companies to join forces. I’m very confident that this will also bring our Qarad team to a higher level, without compromising our own identity and our strong brand. Our current client portfolio will surely benefit from the broad level of expertise within QbD and vice versa. Another huge asset is our strong international presence, with offices in Belgium, Italy, the Netherlands and the UK, and customers in more than 25 countries worldwide.”
With the addition of the 32 Qarad collaborators to the group, QbD currently employs about 430 employees in Belgium and abroad.