Hannelore Bonci

With 15 years of industrial experience in Quality and Regulatory Affairs, I joined nexialist in February 2018 in order to support our clients in the transition to the new Regulations.

During my various experiences, I have notably set up complete Quality systems, proceeded to international registrations (USA, China, Australia, Brazil, Canada) for medical devices of various classes including class III implantable devices.

Certified Lead Auditor, I have performed numerous audit missions (internal or subcontractors) in the framework of the MDSAP standard, Regulation (EU) 2017/745 and 2017/746.

After 4 years spent supporting our clients as a Quality and Regulatory Affairs consultant and then as a Client Project Manager, I now hold the position of Group Quality Manager within nexialist.