Mariceles Mendoza
Managing Director
MFORCE3 Medical Device Consulting
Mariceles Mendoza is an accomplished professional who has dedicated over 26 years of her career to the dynamic and ever-evolving fields of medical devices, biologics, and pharmaceuticals. Her expertise encompasses compliance with not only U.S. regulations such as 21 CFR but also international standards including ISO 13485, EU Medical Device Regulation (MDR), Medical Device Directive (MDD), Canadian Medical Devices Regulations (CMDR), ANVISA in Brazil, J-PAL in Japan, and TGA in Australia. This global perspective and commitment to excellence have enabled her to drive successful regulatory strategies for organizations operating on a global scale.
In her role as the Managing Director of MFORCE3 Quality Concepts LLC, Mendoza offers a holistic approach to support medical device manufacturers throughout their product's lifecycle journey. From the initial spark of an idea to the eventual end-of-life phase, she provides invaluable guidance. Drawing on her deep knowledge of regulatory affairs, compliance, and quality management systems, Mendoza aids in strategic planning, design and development phases, and critical compliance activities.
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