About us

Qarad is a consulting company, specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry.
Thanks to our wealth of experience in the field, Qarad is the ideal partner for all your RA/QA concerns:

Our in-depth knowledge of IVD and MD regulations in combination with the strong belief that new technologies should make our customer’s life easier, also resulted in the development of our eIFU services. Our solution helps manufacturers to distribute their technical documentation via a digital platform. We differentiate ourselves in the eIFU field by offering a single supplier solution, developed by regulatory experts with a focus on compliance and risk management.

Testimonials

Certifications and affiliations

ISO 13485
Certified

ISO-certi

Qarad is an ISO 13485:2016 certified company. ISO 13485:2016 is the standard for a quality management system focusing on the ability to provide products and services that meet all regulatory requirements for medical devices.

Our certificate covers “The sales and provision of consulting, training, authorized representative, performance evaluation and e-labeling services for the medical devices industry.”

ISO 27001
Certified

ISO27001

As ISO27001:2013 certified company, Qarad complies to the high standards for Information Security!

Consultant Agréé
(Walloon region)

Dirk--wit

Dr. Dirk Stynen, Qarad’s founder and President, is consultant agréé for the Walloon region.

Walloon companies can apply for funding for his service

Qarad is a member of several associations

FlandersBio is a non-profit organization for the life sciences and biotechnology sector in Flanders.
The European Association of Authorized Representatives is an alliance of EC-REPs to promote professional conduct and competence.
Ms. Kirsten Van Garsse, consultant at Qarad, is member of the Regulatory Affairs Professionals Society (RAPS)
Qarad EC-REP BV is officially a member of the British In Vitro Diagnostics Association

Qarad is part of the QbD Group

We are proud to be a member of the QbD Group which supports life science companies worldwide throughout the entire product lifecycle – from idea to patient.

Together, we form a multinational organization with over 450 high-qualified employees offering services in regulatory affairs, clinical, qualification & validation, quality assurance, quality control, software solutions and go to market. 

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