Eljar Amini-Nejad

Eljar Amini-Nejad has worked in the medical device industry for more than 10 years. At NSF, he is responsible for client engagement, service definition and helping clients understand and interpret their needs, aims and objectives.

In his career, Eljar has assisted various stakeholders in the industry by providing expert support in the implementation of current regulatory topics covering the entire product life cycle of a medical device. Within the product life cycle, he focuses on the centric approach to risk management as well as device usability and clinical considerations during and after development. Eljar has experience with customizing this approach to suit a wide range of devices of varying complexity.

In addition to his expertise in risk management, Eljar is a trainer for a variety of organizations, including TÜV SÜD and DIN - German Institute of Standardization as well as Vorest AG, for technical documentation, international registrations, post-market surveillance, vigilance, clinical evaluations, usability and human factors.

Eljar holds a Bachelor of Science in medical engineering from the University of Applied Sciences in Hamburg, Germany, and has authored some extremely popular articles, including Two of the Most Common IVDR Challenges (With Solutions).

Areas of Expertise:

• Regulatory Affairs
• Technical Documentation
• EU Medical Device Regulation (MDR)
• Risk Management Systems
• Usability and Human Factors
• Quality Management Systems
• Audits and Inspections
• Vigilance and Post-Market Surveillance