Dragan Jovic

Sigma Systems

Dragan Jovic is a military telecommunication engineer. He started his career as a Military Officer, Tactics Instructor, company commander and operational planning officer. He comes to the Medical Device domain with a background in telecommunications and software.
Dragan is a regulatory consultant with 6+ years of experience with a demonstrated history of practical work in the Medical Device field, focusing on the development and implementation of numerous regulatory strategies regarding the design and manufacture of various medical devices in the EU. Dragan’s practice includes assisting clients in the preparation and implementation of QMS documentation according to ISO 13485, and assisting with all the aspects of the medical product life cycle. For the past 5 years, Dragan Jovic has worked on various projects in medical branches (cardiology, diagnostic radiology, neurology, genetics, physical medicine, etc.) as regulatory support on the development of medical products which involve the use of health informatics, telehealth and artificial intelligence.
In addition to his role at Sigma Systems, he shares his regulatory knowledge and experience as a Lecturer at the Serbian Institute for Standardization.
Dragan is a technical documentation assessor-expert/participant in certification procedure for Serbian certification body, ISO 13485 lead auditor and MDSAP auditor.
Dragan has extensive and practical experience in:
• CE Mark requirements for medical devices,
• Software as Medical device,
• Risk Management,
• Post Market Surveillance,
• Usability Engineering,
• Validation protocols and procedures.