A PARTNER IN MAINTAINING YOUR QUALITY MANAGEMENT SYSTEM
Founded in 2014 and headquartered in Santa Barbara, California, ISO-AID LLC supports small and mid-sized organizations in developing, maintaining, and strengthening their quality management systems. With extensive experience implementing and auditing against ISO 13485:2016 and ISO 9001:2015, ISO-AID provides comprehensive audits with clear, actionable reporting that help organizations meet regulatory expectations with confidence. This expertise has become especially valuable under FDA’s new Quality Management System Regulation (QMSR), which formally incorporates ISO 13485:2016 and elevates its importance for U.S. medical device manufacturers.
ISO-AID’s consulting services are designed for flexibility and accessibility—offered remotely, onsite, or through hybrid engagement models—and backed by certified proficiency in conducting internal audits. Beyond routine assessments, ISO-AID brings practical experience supporting clients during registration audits and providing guidance when organizations are called into FDA offices for discussions or follow-up actions. Leveraging a strong foundation in data analytics, ISO-AID delivers insights that enhance compliance, improve operational efficiency, and support sustainable long‑term growth.
