Quality Systems Compliance LLC was founded in 2012 by Mark Allen Durivage. He saw an opportunity to serve the needs of businesses working in FDA-regulated Industries including Medical Devices, Pharmaceuticals, Tissue, and Food. He has since expanded his business to non-FDA-regulated industries involved with ISO 9001 quality management systems, ISO 14001 environmental management systems, ISO TS 16949 quality management systems requirements for automotive production and relevant service part organizations, and ISO/IEC 17025 general requirements for the competence of testing and calibration laboratories. Our company specializes in Quality Compliance, Quality Assurance, Quality Systems, and Quality Control. Quality Systems Compliance, LLC supports FDA- and ISO-regulated organizations through Auditing, Training, and Consulting services.
Based in lower Michigan near the Ohio border, Mr. Durivage is readily available to support companies and organizations in the Michigan, Ohio and Indiana areas, and he regularly travels throughout the U.S. and abroad to provide Auditing, Training and Consulting services.
Mark Allen Durivage is the author of numerous books and industry guidelines and is widely regarded as an expert on Quality Control, Quality Systems, FDA and ISO Regulations Compliance, and Training to ensure employees can effectively support the goals of their employment company.