Adi Azulay, B.Sc., ICQE
QA & RA Medical Device Project Manager & Team Leader
Adi has 6 years experience consulting for and supporting start-up companies in the field of medical devices.
She established quality management systems that meet the requirements of ISO13485, ISO9001, MDR and 21 CFR 820 and supported their maintenance. She has experience in trainings for QMS, Technical Writing and Quality culture.
In addition, Adi established in regulatory submissions to the European authorities, according to the MDD/ MDR/ PPE and to the Israeli authorities (AMAR). She has experience in the field of combination products and in the field of Virtual manufacturer.
At Gsap Adi participated in projects for the following companies: Biosense webster, DIR Technologies, Lyra Medical, Equashield, G&G Biotechnology, Taro, Teva medical, Dr. Korman, Go Wiz, Ice Cure, Ivory Graft, Aviram Industries, etc..