ABOUT US
Elissa Burg
Founder, CEO
Senior RA & QA Consultant
Elissa has over 25 years of experience in management of Quality Assurance and Regulatory Affairs in the Medical Device industry.
Expertise in global corporates and start-ups of international R&D projects, in regulatory activities with the FDA, European Notified bodies, CFDA, MHLW, Health Canada and International Registrations.
Proven record of accomplishments in obtaining regulatory approvals for medical devices that perform clinical treatment for Cardiovascular, Urology, Gynecology, Otology, Orthopedics, Ophthalmic, Gastroenterology and Medical Aesthetic procedures.
Extensive knowledge of GMP regulation, Quality Assurance and compliance including experience with FDA and Notified Bodies audits.
Prior to the establishment of BioVision Ltd., Elissa was the Global Director of RA & QS at Lumenis Ltd, Elissa was responsible for 3 business units that consist of Aesthetic, Surgical and Ophthalmic products. Prior to joining Lumenis, Elissa served as the VP QA & RA at Allium Medical Solutions and was responsible for all Quality and Regulatory Affairs activities for its daughter companies, Allium Ltd, IBI Medical and Gardia Medical. Elissa served previously as the QA & RA Director at Plastmed Ltd. and EQUASHIELD Medical Ltd. and was responsible for obtaining the first FDA clearance and CE mark for the EQUASHIELD Closed System.
Elissa holds a BSc in Biology from the Hebrew University of Jerusalem.