Steven Rakitin

Consultant, Software Engineering

Steven R. Rakitin has over 40 years experience as a software engineer and software quality manager. He has written extensively on the subject of software quality and published a book titled Software Verification & Validation for Practitioners and Managers, 2nd ed.

He has worked on several IEEE Software Engineering standards committees and was a member of the AAMI HIMSS CE-IT Collaboration team. As a member of a joint AAMI/FDA committee, he helped write the Recommended Practice for the Application of Quality Management System Concepts to Medical Device Data Systems, AAMI SW87:2012.

He received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He has earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a member of the IEEE Computer Society, ASQ Software Division, ASQ Biomedical Division, and the Association for the Advancement of Medical Instrumentation (AAMI), and the Massachusetts Medical Device Industry Council (MassMEDIC). He is on the Editorial Review Board for the ASQ Journal Software Quality Professional. He has presented invited papers and tutorials at conferences worldwide for the Health Industry Manufacturers Association, AAMI, ASQ, and IEEE.

As president of Software Quality Consulting Inc. (www.swqual.com), he helps medical device manufacturers comply with regulations and standards for software. He has worked with over 85 medical device manufacturers including startups through Fortune 500 companies. He can be reached at [email protected].

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