MANAGEMENT
Muzaffer TUZCU, MD
Co-Founder, Chief of R&D and Innovation
Dr. Tuzcu was trained as a Thoracic and Cardiovascular Surgeon. In
his 17-year career as a surgeon, he has had extensive experience
in the operating room, intensive care unit, emergency care units,
wards, and out-patient clinics in the first-hand use of a wide
range of medical devices. He has also participated in the medical
device purchasing processes of the hospitals he has worked in.
Throughout his surgical career, Dr. Tuzcu has published clinical
research papers, translated several medical textbooks from English
into Turkish, and has served as the editor of a medical journal
for many years.
Dr. Tuzcu has worked in the medical device sector as a consultant
for more than 23 years now. He has deep sectoral experience in
medical device training, quality management systems, MDD/MDR
document preparation and review, ETO sterilization/production
process validation, R&D/product line development, and adoption of
new production technologies into the medical device sector.
Ayça Batmaz, MSc. Biomedical Engineer
Co-founder, General Manager
Ms. Ayça Batmaz has received her Bachelor of Science Degree in
Bioengineering, from Istanbul Technical and Montana State
Universities. She has also received her Master of Engineering
degree in Biomedical Engineering from the University of Texas, at
Arlington.
Before she started her career in the medical device sector, she
also had experience in manufacturing thermoplastic compounds in a
manufacturing facility located in Georgia, USA.
She has worked on clinical evaluation reports, regulatory
compliance processes, and post-market surveillance activities for
3 years in the medical device industry. She has experience in
designing and executing post-market clinical follow-up studies
within the scope of disposable, implantable, and electro-medical
devices.
She carried out studies on statistical data analysis,
device-specific clinical performance and safety data collection
and appraisal, and state-of-the-art benchmarks of medical devices,
along with the implementation of usability engineering, risk
management, and biological evaluation process within the context
of quality management systems for medical devices.
