Sivan Luder, PhD

Quality and Regulatory Project Manager

Regulatory, Clinical, and Quality Expert with a PhD in Molecular Biology and over 10 years of experience across various industries, with a strong focus on the medical device sector. Possesses a deep scientific background and extensive experience in leading the development and implementation of medical devices from concept to commercialization, managing regulatory projects, and preparing international submissions. Skilled in establishing, implementing, and maintaining Quality Management Systems (QMS) and in preparing for and supporting audits, with a proven track record of leading and successfully managing EU and ISO 13485 audits.

Dr. Sivan Luder is a Regulatory, Clinical, and Quality Expert with a PhD in Molecular Biology and over 10 years of experience across various industries, with a strong focus on the medical device sector.

Possesses a deep scientific background and extensive experience in leading the development and implementation of medical devices from concept to commercialization, managing regulatory projects, and preparing international submissions. Skilled in establishing, implementing, and maintaining Quality Management Systems (QMS) and in preparing for and supporting audits, with a proven track record of leading and successfully managing EU and ISO 13485 audits.