Steven R. Rakitin has over 45 years’ experience as a software engineer including 35 years of experience in the medical device industry. He has worked with over 130 medical device manufacturers worldwide, from startups to Fortune 100 corporations. He has published papers on medical device software risk management as well as a book titled: Software Verification & Validation for Practitioners and Managers.
As President of Software Quality Consulting, Steve helps medical device companies comply with FDA and EU regulations, guidance documents, and international standards in an efficient and cost-effective manner.
Steve received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a Senior Life member of IEEE.
