Felipe S.

With 10 years of experience in developing hardware, firmware, and documentation for medical devices and Software as a Medical Device (SaMD), I have specialized in designing safe and compliant systems. I am well-versed in: • IEC 60601-1 (General Safety) • IEC 60601-1-2 & IEC TR 60601-4-2 (EMC) • IEC 62304 (Medical Software) • ISO 13485 (QMS) • ISO 14971 (Risk Analysis) • IEC 60601-2-57 (Non-laser light) • IEC 60601-2-18 (Endoscopes) • IEC 60601-2-83 (Heat lamps) • IEC 62471 (Non-laser light risk) • IEC 60825-1 (Laser safety) • Related FDA guidelines → Hardware Development • End-to-End PCB Design: From schematic capture and layout to prototyping and validation for rigid, flexible, and metal-core substrates. • Specialized Circuit Design: Expertise in analog front-ends for sensitive biometric data, efficient power converters, and robust sensor interface circuits. • Design for Manufacturing (DFM): Creating designs optimized for cost, reliability, and scalability in a production environment. • Supply Chain Coordination: Managing communication and prototyping with component suppliers and PCB manufacturers. → Firmware Development • Microcontroller Expertise: Proficient with a range of architectures, including Atmel/Microchip (Atmega, ATxmega, SAM), STM32, and ESP32. • Programming Languages: Primary development in C for embedded systems, with Python and MATLAB used for testing, automation, and data analysis. • Structured Development: Emphasis on modular code, comprehensive documentation, and verification testing to support regulatory audits. → Regulatory Pathway • Regulatory Strategy & Liaison: Acting as your technical interface with certification bodies and test labs. • Documentation Authoring: Hands-on creation of all necessary technical file documents, including: --- Product Requirements & Design Specifications --- System and Software Test Plans --- Risk Management Files (per ISO 14971) --- Software documentation (per IEC 62304 and FDA guidance) • Testing Management: Developing test plans and managing the compliance testing process with my network of ILAC-certified labs, ensuring significant cost savings compared to European or American labs.