Affiliations and certifications

Certifications

Qarad is certified for:

• ISO 13485:2003: a standard for a quality management system focusing on the ability to provide products and services that meet all regulatory requirements for medical devices. The certificate covers "The sales and provision of consulting, training, translation, authorized representative, performance evaluation and e-labeling services for the medical devices industry and test laboratories." Download (.pdf 941 KB) »
• KMO-portefeuille: Qarad is recognized by the Flemish Government to give advise and training to enterprises. With the KMO-portefeuille, a SME (Dutch: KMO) can apply for funding to get highly qualified training and advise.

Dirk Stynen is:

• Consultant Agréé (Walloon Region). Walloon companies can apply for funding for his services. 

Affiliations

Qarad or its employees are member of several associations:

• FlandersBio, a non-profit organization for the life sciences and biotechnology sector in Flanders.
• WAL-Dx, the Diagnostics division of BioWin, the Health cluster of Wallonia.
• EAAR, the European Association of Authorized Representatives, an alliance of EC REPs to promote professional conduct and competence.
• RAPS, the Regulatory Affairs Professionals Society, an international organization for regulatory professionals to ensure high quality of healthcare products.