This session presents a real-world journey of pursuing ISO 13485 certification within an in-house Clinical Engineering department at a large academic medical center. Attendees will learn how ISO 13485 requirements were interpreted, operationalized, and integrated into existing maintenance, quality, and compliance workflows. The presentation will focus on governance structure, documentation strategy, risk-based thinking, and staff engagement rather than theory. Lessons learned, common pitfalls, and practical takeaways will be shared to help other organizations assess feasibility and readiness for certification.