George Hattub, RAC

I recently retired from Johnson & Johnson where I specialized in PMA class 3 orthopedic implantables. I have achieved more than 70 FDA 510(k) clearances over 30 years, including 14 Special 510(k) clearances and 4 Breakthrough Device Designations. I led an engineering team in the commercialization of a revolutionary medical device for staging blood cancers in which we won a Silver Award for Medical Device Innovation in 2001. In addition, I advised an AI/ML startup for over 10 years from inception to a successful acquisition for over 100 million dollars. I have advised on 2 projects which led to MRI’s being used during brain surgeries and being placed near the Neonatal ICU. During the Pandemic, I obtained an Emergency Use Authorization from the FDA and later obtained the 510(k), with clinical data from the Mayo Clinic, for a therapeutic medical device to help patients recover from COVID. When the remote work revolution became a reality, I established a successful side-hustle which led to over 80k dollars in earnings and top rate status because a the magnitude of positive customer feedback. Currently, I am a mentor and lecturer for the Master’s Program at a world renowned university. I have survived 9 face-to face FDA Inspections (survival = no Warning Letter). Yearly, I donate a percentage of my time Pro Bono to advance medical device technologies which are worthy and will make a difference. I hold RAC, ASQ Certified Quality Engineer, and ASQ Certified Medical Device Auditor credentials.