FDA Regulations and ISO Standards
Quality Cavalry can help guide your organization with FDA 21 CFR 820 regulations and ISO standards related to quality. Gary has experience with quality regulations in organizations that produced Type II and Type III medical devices.
Gary is also familiar with FDA software validation guidance, ISO 13485:2003, ISO 14971:2007, ANSI/AAMI/IEC 62304:2006, ISO 9001:2000 and ISO/TS16949. Gary has also worked as an internal TS16949 assessor.