Joshua Galecki is a consultant specializing in medical device cybersecurity and FDA regulatory compliance. With over five years of hands-on experience developing secure software and supporting regulatory submissions, he helps startups and established manufacturers navigate the complex landscape of FDA cybersecurity expectations with confidence and clarity.

Joshua has successfully contributed to multiple 510(k) submissions, creating cybersecurity risk assessments and threat models, developing SBOMs, and responding to FDA review questions. His work bridges the gap between technical rigor and regulatory compliance, ensuring clients not only meet FDA requirements but build defensible devices.

Prior to his work in cybersecurity, Joshua spent over three years as a registered nurse, providing inpatient care at leading institutions including Cleveland Clinic and Brigham and Women’s Hospital. His combination of clinical and technical expertise gives him an exceptional perspective on safety, usability, and patient impact in medical technology.