"Focused on Solutions", our solution oriented approach is the basis for our consulting services. The company founder has many years of experience as a responsible compliance manager in the medical device industry and therefore knows all the needs and critical requirements in this industry.
QUNIQUE's core competency is the exact knowledge of the requirements and needs of the customers or manufacturers in the field of medical devices (MDR, MDSAP, ISO13485 updates).
QUNIQUE was founded in May 2017 by Angelina Hakim. We are specialized in developing tailored concepts to support, maintain and improve compliance of our customers in the medical device industry.
QUNIQUE is fully focused on the requirements and needs of manufacturers. The company works with a broad network of partners.
The offer is rounded off by perfectly tailored seminars and training courses in MDR (Medical Device Regulation), QM (Quality Management), RA (Regulatory Affairs) and Audits Preparations.
Angelina Hakim is the founder and CEO of QUNIQUE GmbH. She holds a masters degree in Biomedical Engineering from the University of Applied Sciences in Hamburg. Later on she accomplished her certification as a Regulatory Affairs professional for Medical Devices at the RAPS University.
Angelina holds additionally numerous certificates in Quality Management and as an internal auditor. Angelina lives in Switzerland since 2010. Thanks to her extensive experience in internationally renowned Medical Device manufacturing and consulting companies, she can count on a wealth of experience in the areas of Quality Management, Regulatory Affairs and Program Management.
Her experience as a consultant and the cooperation with other consulting companies round up her profile.