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SIGMA SYSTEMS Team


Aleksandar Šišković
Function
CEO / Quality Systems Specialist and Regulatory Affairs Consultant

Qualification
ISO 13485, MDSAP, FDA QSR 21 CFR Part 820, MDD (93/42/EEC), CE Mark (EU), Regulation (EU) 2017/745, MDR - CE marking and FDA approval of Medical Device, IVD, CMDR, ISO 9001, ISO 19011, ISO 14001, ISO/IEC 27001, FDA QSR 21 CFR Part 11, ISO/IEC 20000-1, ISO 37001, ISO 14971, IEC 62304, IEC 62366, IEC 60601.
✓ MDSAP Certified Auditor
✓ External Auditor ISO 13485, ISO 9001, ISO 14001, ISO/IEC 27001, ISO/IEC 20000-1, ISO 37001

Education
Graduated Engineer of Electronics Faculty of Electronic Engineering, University of Nis, Serbia.



Vladimir Petrović
Function
IMS and Regulatory Specialist

Qualification
ISO 13485, MDD (93/42/EEC) CE Mark (EU), FDA QSR 21 CFR Part 820, Regulation (EU) 2017/745, MDR - CE marking and FDA approval of Medical Device, ISO 9001, IATF 16949, ISO 14001, ISO/IEC 27001, ISO/IEC 20000-1, ISO 14971, IEC 60601, ISO 19011, ISO/IEC 17025, ISO 31000, 8D Reports, Problem Solving Tools.

✓ External Auditor ISO 9001,
ISO/IEC 27001, ISO/IEC 20000-1, ISO 14001, ISO 45001

✓ Internal Auditor ISO 13485, ISO 14001, VDA 6.3, VDA 6.5, IATF 16949

Education
Graduated – Master of Electrical Engineering and Computing in the field of Control Systems, Faculty of Electronic Engineering, University of Nis, Serbia.



Emilija Grujić
Function
IMS and Regulatory Specialist

Qualification
ISO 13485, MDSAP, ISO 9001, Regulation (EU) 2017/745, MDR - CE marking and FDA approval of Medical Device, ISO 14971, ISO 45001, ISO 18001, ISO 14001, ISO 22000, FDA QSR 21 CFR Part 820, ISO 19011.
✓ MDSAP Certified Auditor
✓ External Auditor ISO 13485, ISO 9001
✓ Internal Auditor ISO 9001, ISO 13485, ISO 14001

✓ Licensed Health and safety responsible person

✓ Licensed Fire safety responsible person


Education
Graduated – Master in Environmental Safety (Environmental Safety Engineering), Faculty of Occupational Safety in Nis, University of Nis, Serbia.


Dragan Jović
Function
Regulatory Specialist and Medical Software Consultant

Qualification
ISO 13485, MDSAP, ISO 9001, MDD (93/42/EEC), IVD, CE Mark (EU), Regulation (EU) 2017/745, MDR - CE marking and FDA approval of Medical Device, FDA QSR 21 CFR Part 820, ISO 14971, IEC 62304, IEC 62366, IEC 60601, ISO 19011, FDA QSR 21 CFR Part 11, ISO/IEC 27001.
✓ MDSAP Certified Auditor
✓ External Auditor ISO 13485, ISO/IEC 27001
✓ Internal Auditor ISO 9001, ISO 13485


Education
Graduated Military Telecommunication Officer, Military Academy, University of Defence in Belgrade, Serbia.




Danijel Zadravec
Function
Quality Systems Consultant

Qualification
ISO 9001, ISO 13485, FDA QSR 21 CFR Part 820, Regulation (EU) 2017/745, MDR - CE marking and FDA approval of Medical Device, ISO 14971, ISO 19011.
✓ Internal Auditor ISO 9001, ISO 13485




Education
Graduated Engineer of Electronics Faculty of Electronic Engineering, University of Nis, Serbia.


Milena Šišković
Function
Regulatory Consultant

Qualification
ISO 13485, FDA QSR 21 CFR Part 820, MDD (93/42/EEC), CE Mark (EU), Regulation (EU) 2017/745, MDR - CE marking and FDA approval of Medical Device, ISO 10993, ISO 14971, ISO 9001, ISO 19011.
✓ External Auditor ISO 13485
✓ Internal Auditor ISO 9001

Education
Master of Pharmaceutical and Cosmetic Engineering, Faculty of Technology, University of Nis, Serbia.



Miroslav Mičić
Function
Quality Systems and IT Consultant

Qualification
ISO 13485, ISO 9001, FDA QSR 21 CFR Part 820, Regulation (EU) 2017/745, MDR - CE marking and FDA approval of Medical Device, ISO 14971, ISO 19011.
✓ Internal Auditor ISO 9001, ISO 13485


Education
Graduated Engineer of Electronics Faculty of Electronic Engineering, University of Nis, Serbia.



Tamara Pešić
Function
Quality Systems Consultant

Qualification
ISO 9001, ISO 13485, FDA QSR 21 CFR Part 820, Regulation (EU) 2017/745, MDR - CE marking and FDA approval of Medical Device, ISO 14971, ISO 19011.
✓ External Auditor ISO 9001
✓ Internal Auditor ISO 9001, ISO 13485

Education
Master of Science in Electrical Engineering and Computing, Faculty of Electronic Engineering, University of Nis, Serbia.



Nikola Stojanović
Function
Quality Systems Consultant

Qualification
ISO 13485, ISO 9001, FDA QSR 21 CFR Part 820, IATF 16949, 8D Reports, Problem Solving Tools, MSA, PPAP, SPC, APQP, FMEA, Control plan, ENEC, CCC, KC safety requirements, IPC-610-A, ESD IEC 61340, ISO 14971, ISO 19011.
✓ External Auditor ISO 13485, ISO 9001
✓ Internal Auditor ISO 9001, ISO/TS 16949


Education
Master Engineering Management Faculty of Mechanical Engineering, University of Nis, Serbia



Milan Radenković
Function
Quality Systems and ICT Consultant

Qualification
ISO/IEC 27001, TIA/EIA 568, ISO/IEC-11801, ANSI/TIA/EIA-568, ITIL, SSL, TLS, GDPR, ISO 9001, ISO 13485, FDA QSR 21 CFR Part 820, Regulation (EU) 2017/745, MDR - CE marking and FDA approval of Medical Device, ISO 14971.
✓ External Auditor ISO 13485, ISO/IEC 27001
✓ System / Network / Security Administrator

Education
Graduated Engineer of Electronics and Telecommunications, Faculty of Electronic Engineering, University of Nis, Serbia



Jelena Majstorović
Function
Regulatory Affairs Consultant

Qualification
ISO 13485, Pharmacy technician license, Regulation (EU) 2017/745, MDR - CE marking, Regulation (EU) 2017/746, IVDR - CE marking, FDA QSR 21 CFR Part 820, ISO 9001, ISO 14971, ISO 19011.
✓ External Auditor ISO 13485

✓ Experienced pharmaceutical practitioner

✓ Skilled in adverse drug effects and safety and efficacy of analgesic combinations


Education
Bachelor of Laws, University of Kragujevac, Serbia.






Miloš Ilić
Function
Regulatory Affairs Consultant

Qualification
ISO 13485, Serbian regulation on medical devices (Law on medical devices, Official gazette of RS, 105/2017 and the corresponding guidelines), ISO 9001, IVDD (98/79/EC), Regulation (EU) 2017/746, CE marking of medical devices, ISO 14971.
✓ Specialist for Serbian medical device regulation
✓ Implementer of good distribution practice rules for drugs and medical devices

Education
Pharmaceutical care specialist - graduated from the Faculty of Pharmacy, University of Belgrade, Serbia. Master of Pharmacy - graduated from the Medical faculty, University of Nis, Serbia.

Our External Specialists


Prim.dr Miljan Jović
Emergency Medicine Specialist

International Expert in Emergency Medicine
Founder of Serbian Society of Emergency Physicians



Workplace
Head of Emergency Department

Education
Faculty of Medicine Belgrade, Serbia.
PHTLS Instructor, Serbian Red Cross licenced Instructor


dr Sanja Stanković Mičić
Doctor of Dental Medicine (DMD)

Owner of dental office "Moja zubarka"("My dentist"), Niš, Serbia.
Graduated at the Faculty of Medicine in Niš, Serbia, as third student in her generation, with average mark 9.7 ( 10 being the highest).
Practical experience more of ten years in dental areas.

Workplace
Dental office "Moja zubarka"

Education
Faculty of Medicine in Niš, Serbia.