Contact: Ken Miles
Year Established: 2004Led by former FDA investigators, Alpha Quality Assurance Associates provides expert consulting services for U.S. and foreign manufacturers of medical devices, IVD products, and radiological health devices such as x-rays and lasers. Services include site audits, gap analysis, and recommendations for QSR, GLP, and ISO 13485:2003 requirements, documentation, practices, and training. The company has expertise in FDA compliance issues, MDRs, recalls, electronic records, validation, and radiological health performance standards.
