MDM ENGINEERING CONSULTANTS

In 2009, Mercedes started her own consulting firm, MDM Engineering Consultants, to provide consulting services to companies in the medical device, pharmaceutical and biotechnology industries. Mercedes has helped her clients commercialize new innovative and highly advanced software controlled medical devices. Some of the most exciting devices that she has worked on include high-volume infusion pumps, pain management infusion pumps, insulin pumps, heart valves, surgical robots, and respirators. Highlights from her consulting career included working on the first FDA-accepted assurance case for an infusion pump. Since that time, Mercedes has been involved in FDA approval of numerous infusion pump assurance cases. Mercedes has also helped her clients reduce product development cycle time while improving regulatory compliance. Mercedes is well versed in the requirements of the FDA QSR, ISO 9001, ISO 13485, IEC 62304, IEC 60601, IEC 62366, ISO 14971. Mercedes has also helped companies with..

Also known as: mdmeng