Andrew Wainaina

Andrew Wainaina

Andrew is a globally seasoned technology, risk, and security specialist with over two decades of international experience managing complex technical infrastructure across the United States and East Africa. Holding dual Bachelor of Science degrees in Information Security & Assurance and Computer Science from Kennesaw State University (USA), he bridges the critical gap between physical engineering, software system validation, and digital threat mitigation.

At exFDA Consultants, Andrew serves as a core subject matter expert in securing medical devices and medical software systems. He specializes in identifying and controlling cybersecurity vulnerabilities, steering rigorous software validation protocols, and executing hands-on penetration testing to ensure absolute system integrity. His technical oversight directly supports design control activities and risk management frameworks designed to mitigate cyber-based hazards before they can jeopardize patient safety or regulatory approval.

In addition to his technical engineering focus, Andrew directly supports clients facing complex regulatory actions—assisting with FDA submissions, warning letter and 483 inspectional observation responses, product holds, and recalls. He routinely serves as an essential technical scribe and support lead during high-stakes mock inspections and regulatory audits.

Prior to joining exFDA Consultants, Andrew held senior, enterprise-level security engineering and risk consultation roles for major global organizations, including managing critical infrastructure projects for Kennesaw State University (integrating emergency warning networks with FEMA), InfoSec Analytics, The World Bank, and multinational security firms. His deeply rooted background in business continuity, technical security auditing, and systems validation gives exFDA clients unparalleled protection against modern digital and operational risks.