This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and ANSI/AAMI/ISO 13485:2016.

Upon completing this program, participants will take home the knowledge to examine their quality management system to determine if it complies with both FDA Quality System requirements and 13485 requirements and recognize where improvements are needed. Participants will learn about the FDA inspectional approach and the Medical Device Single Audit Program. This course will empower the attendee with the knowledge to successfully host a FDA/MDSAP audit.

Instruction is targeted to professionals directly involved in meeting both FDA and international quality system requirements or those who are ultimately responsible for compliance, including harmonization with 13485. To maximize the peer learning opportunity, AAMI recommends this course for those who already have a basic understanding of a quality management system.

Fee includes a printed copy of the textbook, The Quality System Compendium, and electronic versions of ANSI/AAMI/ISO 13485:2016, the PowerPoint presentations and case studies, pertinent FDA documents, additional references, and access to the online exam.