Mike Zaavi

Mike Zaavi is a senior consultant and recognized thought leader in software validation, IT systems, and regulatory compliance within the biomedical industry. He brings extensive hands-on experience supporting medical device manufacturers, pharmaceutical companies, biotechnology organizations, and clinical trial environments. Mike specializes in software validation and software quality assurance, with deep expertise in regulatory requirements including 21 CFR Part 11 and Annex 11 of the FDA and EMA, particularly in the areas of electronic records, electronic signatures, and computerized systems validation. Over the years, he has guided numerous organizations through the validation of both core operational and supporting software systems, ensuring regulatory compliance and operational efficiency. Mike has played a central role in the establishment and implementation of FDA- and CE-compliant software quality systems across Israel, contributing directly to the successful deployment of validated systems that operate effectively in regulated production and development environments. His work is characterized by practical insight, regulatory rigor, and a strong ability to translate complex requirements into workable, compliant solutions.