MD EXPERT CONSULTING AGENCY
Specialised Regulatory & Quality Support Affairs for Medical Devices across SouthEast Europe, Middle East and Africa.
ABOUT MD EXPERT
Committed to Excellence
MD Expert is an independent Regulatory and Quality Support Affairs agency specialised in Medical Devices focused on SouthEast Europe, Africa and Middle East.
Dr. Slobodanka Marcetic-Rajic founded MD Expert after over 30 years of working for influential medical-health houses leading Regulatory and Business Quality for CEE non-CE mark countries. (Countries that accept the CE certificate but are not in the EU and require additional registration.)
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Dr. Slobodanka Marcetic-Rajic is a published clinical pharmacologist and toxicologist with expert knowledge of regulatory requirements (having led compliance across 8 countries) with the ability to translate regulations into clear data requirements for all medical device risk classes.
She is a seasoned professional with an in-depth understanding of how regulation impacts product registration and market access. She brings an analytical mindset, project management experience, and a leadership background in a multinational, cross cultural setting.
SERVICES & EXPERIENCE
30 years of work experience in regulatory and quality support across 8 countries
SERVICES
Full regulatory and quality support for medical devices across SouthEast Europe.
Slovenia, Croatia, Bosnia and Herzegovina, Serbia, Montenegro, Macedonia, Kosovo, Albania, Bulgaria and Romania.
Full regulatory and quality support for medical devices in Africa and Middle East.
Consulting expert familiar with global regulatory affairs.
STRENGTHS
Project management and execution
Expert knowledge of regulatory requirements
Experienced in Business Quality (SOP,WI, GAP Assessments, CAPA, CCRs)
Experienced in digital and e-Health communication
CERTIFICATION & QUALIFICATIONS
Vigilance and Medical Device Reporting (Johnson & Johnson 2019)
Certified External Auditor by TUV, Germany for ISO 9001:2008, Quality Management System (QMS) (2007)
PhD in Pharmacology and Toxicology (Veterinary College, Belgrade and Military Medical Academy,2005)
DVM Veterinary surgeon (Veterinary College, Belgrade, Serbia, 1989)
AFFILIATIONS AND PUBLICATIONS
INOVIA (Association of innovative producers of drugs and medical devices in Serbia)
AmCham (USA chamber of commerce)
Investigation of subchronic toxicity of chloramphenicol in poultry, FVM, 2005 (language of publication, Serbian)
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