About us

Focused on Solutions”…

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.

Management Board

  • Angelina Hakim

    Founder, CEO and Co-Owner

  • Dr. Bassil Akra

    CEO and Co-Owner

Angelina Hakim

Founder, CEO and Co-Owner

Biography

Angelina Hakim is the founder, Co-Owner and CEO of QUNIQUE GmbH.
She developed her experience through the different stations of her career at global medical devices manufacturers as well as consulting organizations.
At Olympus Winter & Ibe, Institut Straumann and Schiller AG she was exposed to medical devices from classes I to III and was responsible for documenting and establishing procedures, work instructions and compiling the technical documentation in compliance with applicable international standards and regulations.
Thanks to her detailed knowledge of MDR 2017/745, IVDR 2017/746, Medical Devices Single Audit Program (MDSAP) and ISO 13485 requirements, Angelina is able to combine her past experience with the new requirements to train and support many customers around the world to adapt their quality systems and update their product technical documentation.

Dr. Bassil Akra

CEO and Co-Owner

Biography

Dr. Bassil Akra is CEO and Co-Owner of QUNIQUE GmbH. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and globally the notified body association in the various European discussion.
Dr. Akra was the Vice President of strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products.
Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.).
He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.

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