MDM Engineering Consultants
Prior to starting her own consulting firm, Mercedes worked for several major players in the medical device industry. From the mid-1980’s to the late 1990’s, Mercedes worked developing pacemakers. While releasing four different pacemaker models to market, Mercedes held a number of roles which contributed to honing her skills and understanding how to release quality products in a regulated industry. Mercedes had extensive dealings with the FDA during this time and helped her employer emerge from under a consent decree in a mere nine months. In the late 1990’s until 2009, Mercedes worked developing hemodialysis and peritoneal dialysis machines. During this time, Mercedes held several positions of responsibility in quality, verification and validation and systems engineering. Mercedes became a recognized company expert in Product Development, Requirements Development / Requirements Management, Process Improvements and Risk Management. Mercedes also used her talents as a skilled auditor and trainer to improve company performance.
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 software products classified as Electrical Medical Record (EMR) or Class I medical devices get to market using a least burdensome approach.
Mercedes D Massana, Founder & CEO
email@example.com | Phone: 954-829-0632
Mercedes Massana offers more than 30 years of management and technical expertise in the medical device industry. With a unique skill set that combines expertise in quality management in regulated industries and superb skills in systems engineering and software development / validation, Mercedes is able to help her clients reach the right balance in developing compliant solutions for commercializing medical devices on time, exceeding quality expectations and within budget.
Mercedes is an American Society for Quality (ASQ) certified Biomedical Auditor (CBA), Quality Auditor (CQA), Quality Manager (CQMa),and Software Quality Engineer (CSQE). Mercedes also teaches the ASQ CSQE primer course for her local ASQ Section (Section 1510) and she is currently the acting president for the emerging South Florida Chapter of the International Council on Systems Engineering (INCOSE). Mercedes has also served as an expert witness in the area of Software Development and Risk Management. Mercedes is fully bilingual in Spanish and has facilitated workshops and performed training in Spanish.
Mercedes participates in the AAMI Standards Software Working Group and the Application of Risk Management to Medical Devices Working Group.