About us

QUNIQUE was founded in May 2017 by Angelina Hakim. The company is specialized in developing tailored concepts to support, maintain and improve compliance of our customers in the medical device and in-vitro diagnostic sectors.

Our solution oriented approach is the basis for our consulting services. The company resources have many years of experience in the medical device, IVD and combination product sectors and therefore knows all the needs and critical requirements in those business areas.

QUNIQUE’s core competency is the exact knowledge of the requirements and needs of the various stakeholders including manufacturers in the different fields (e.g. IVDR, MDR, MDSAP, ISO13485 updates).

QUNIQUE is fully focused on the requirements and needs of manufacturers. The company works with a broad network of partners.

The service portfolio of QUNIQUE is rounded off by perfectly tailored seminars and training courses in areas such as IVDR (In-Vitro Diagnostic Regulation), MDR (Medical Device Regulation), QM (Quality Management), RA (Regulatory Affairs) and Audits Preparations.