Garrett Technologies, Inc. Information

Garrett Technologies, Inc. is a medical device product development firm specializing in Class I, II, and III devices, complex electronic systems, and safety-critical embedded software. We partner with medical device and healthcare companies to take products from concept through design, verification, validation, and transfer—operating within a structured, ISO 13485-certified quality system aligned with FDA 21 CFR Part 820, IEC 60601, ISO 62304, IEC 61010, and related standards. Our work is grounded in disciplined engineering execution and formal design controls. We integrate electrical engineering, embedded systems, digital signal processing, and algorithm development within a phase-gated development framework that ensures traceability, risk management, and regulatory readiness at every stage. We have led development across a wide range of medical technologies, including diagnostics, monitoring systems, implantable support technologies, wireless medical devices, and opto-electrical systems. Our teams are particularly effective in de-risking complex technical challenges while producing documentation that withstands regulatory and certification scrutiny. How We Work • Structured design controls aligned with FDA and ISO requirements • Phase-gated development with formal design reviews • Integrated program management and engineering execution • Transparent client reporting and rigorous documentation discipline Core Competencies • Class I, II, and III medical device development • Analog, digital, and mixed-signal hardware design • Embedded systems and software engineering • DSP algorithms and signal processing • Risk management and hazard analysis • Design controls, DHF development, and V&V • Wireless, RF, and medical-grade connectivity • Device cybersecurity and coexistence testing • Regulatory and agency certification support