Rajko Topolnjak

Software Validation Expert

Senior Consultant

Rajko is part of Qserve's Regulatory Affairs team and is an expert of Software Validation. Since 2014, Rajko has been working as a consultant for Qserve Group. He provides QA/RA support for the medical device industry, in particular for manufacturers of electro-medical devices and medical software and mobile apps. Rajko has gained knowledge of the Directive concerning medical devices (93/42/EEC), and he has an experience with risk management (ISO 14971), quality management systems (ISO 13485, 21CFR820), clinical evaluation and with writing technical file summaries and underlying documentation.

He gained experience working in medical device industry and academic hospitals. He was working as a scientific software engineer, researcher, design engineer, validation engineer and project manager. Rajko has degrees in Medical Physics (PhD, 2006) and Theoretical Physics (Dipl. Ing. Phys., 2000). He obtained a doctorate for his research at the Department of Radiotherapy at the University Medical Center Utrecht (Utrecht, The Netherlands). His thesis presents design and results of Clinical Investigation of a novel collimator for advanced radiotherapy treatment.

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