CEFALY Technology Benefits Overview

Design, develop, and validate electronic hardware and embedded firmware for medical neurostimulation devices. Perform schematic design, PCB layout review, component selection, and firmware development (C/C++). Execute hardware V&V, EMC and environmental testing per medical standards, produce regulatory documentation (DHF, ISO 14971), and support manufacturing, supplier qualification, and continuous QMS improvements for CE/FDA submissions.

Lead global supply chain, logistics, fulfillment, and import/export compliance. Own supply planning, inventory management, S&OP, 3PL oversight, and continuous improvement to ensure product availability, regulatory compliance, and scalable operations across markets.

Lead and own the electronic QMS and regulatory affairs for a medical device company. Optimize and expand eQMS, ensure compliance with ISO 13485, FDA QSR, and EU MDR, lead audits and inspections, drive CAPA and documentation remediation, manage regulatory submissions, mentor QA/RA staff, and partner cross-functionally to improve quality system maturity and inspection readiness.