SME Profile

Maria Cianciotto

Maria Cianciotto's career spans over 20 years within the medical device industry as a Quality, Regulatory and Clinical Affairs professional. Maria possesses substantial expertise in overall Quality System development and implementation along with extensive experience in the areas of CAPA, Complaint Handling/Adverse Event Reporting, Management Controls, and Design Controls.
She is currently Principal Partner of Quality System Architects Consulting firm which specializes in assisting medical device clients with Quality System Training, process and product remediation under enforcement actions, as well as response writing and interactions with Regulatory Agencies.
Maria is also a published author of Quality/Regulatory Books and articles and recently collaborated on "Inspection Awareness - A Guide to Achieving Quality System Readiness," which is available online at