Advocate MedTech Solutions Information

Advocate MedTech Engineering (AME) provides elite systems engineering and technical advisory services for complex Class II and Class III medical devices, surgical robotics, and software-driven therapeutic systems. Founded and led by Arnold Oyola, a systems engineering leader with 30 years of medical device experience, AME partners with startups and incubators to navigate the critical transition from prototyping to volume manufacturing. Our Philosophy: Architecture Before Execution Compliant development requires establishing the environment, architecture, and overall intent before executing granular tasks. We help teams build the top-down frameworks and proactive risk architectures required to withstand regulatory reviews and scale with absolute predictability. AI Integration: Human-in-the-Loop Integrity AME pioneers the compliant, "human-in-the-loop" integration of AI tools in medical device engineering. We safely leverage AI to accelerate: * Risk Management (ISO 14971): Utilizing LLM frameworks to run hazard analyses, draft FMEAs, and trace risk controls. * Requirements & Protocols: Generating clear system requirements and high-fidelity V&V test protocols. * DHF Auditing: Conducting advanced technical gap analyses across multidisciplinary Design History Files (DHFs). Core Capabilities * Systems Engineering: Defining requirements, system architectures, and hardware, software integration. * Proactive Risk Architecture: Designing risk management strategies per ISO 14971 and embedding controls directly into requirements. * Verification & Validation (V&V): Executing V&V campaigns to build robust, compliance-ready evidence. * Process Scale-Up: Implementing process improvements and statistical analysis to transition prototypes to repeatable production. Contact: Message us directly on LinkedIn.