Nedim Junuzovic Dipl. Ing. of mechanical engineering, graduated from University of Tuzla, Mechanical Faculty and currently PhD student at Mechatronics department. His work experience reaches close to 20 years of work solely in area of Quality and Regulatory affairs.
Over the last 13 years, he has been working on many successful Medical devices development projects, novel medical technologies in USA and Denmark such as hand-held EEG device, portable blood warmer, wearable bruxism biofeedback device, EP Lab equipment, wearable cardio monitor and more.
He is founder and CEO of QualityCert d.o.o. Tuzla, the only MedTech consulting company in Bosnia and Herzegovina. QualityCert is globally providing quality and regulatory services in medical device development and production, and in the region supporting various healthcare organizations.
Since 2010 he is member of Institute for Standardization BiH (BAS), Technical committee BAS/TC 25 Health protection technology and BiH representative member at International Organization for Standardisation (ISO), Technical committee ISO/TC 210 QMS and corresponding general aspects for Medical devices.
As of 2009 he is appointed Lead auditor for management systems and 2014 has been qualified by global Notified Body in Germany as medical devices conformity assessment expert for European regulatory framework (CE marking).
Specialties: medical devices, product development, standardization, conformity assessment, quality management, regulatory affairs, market approvals, technical documentation and design dossiers;