Ela Aziziyan

WORK HISTORY

EDUCATION

ABOUT ELA AZIZIYAN

As an expert in medical device regulatory affairs with a bachelor\'s degree in Biomedical Engineering, I have been working in the industry for the past 10 years. During this time, I have collaborated with several reputable medical device manufacturers and certification and notified bodies, gaining extensive knowledge and experience in various European standards.I am proficient in the implementation and auditing of various European standards, including the Medical Device Regulation 2017/745, Medical Devices Directive (93/42/EEC), ISO 13485 for quality management systems, ISO 14971 for risk management, IEC 62366 for usability engineering, and IEC 62304 for medical device software.My expertise also extends to writing technical files, PMS reports, usability engineering files, clinical evaluation reports, and other necessary documents in coherence with CE marking requirements.My strong background in regulatory affairs, combined with my education and experience, enables me to provide valuable insights and solutions to ensure compliance with regulatory standards and successful market access of medical devices.Here there are some of the regulation and standards that I have dealt with the most during these period:• Medical Device Regulation 2017/745• Medical Devices Directive (93/42/EEC)• ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes• ISO 14971 - Medical devices - Application of risk management to medical devices• IEC 62366 - Application of usability engineering to medical devices• IEC 62304 - Medical device software