Mariceles Mendoza

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. With a wealth of experience under her belt, she has carved a niche for herself as a trusted advisor and subject matter expert in critical areas such as regulatory compliance, regulatory affairs, and quality management systems.

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, Mariceles offers a holistic approach to support medical device manufacturers throughout their product's lifecycle journey.

Before taking the helm at MFORCE3 Quality Concepts LLC, Mariceles occupied senior positions at prestigious industry leaders such as Zimmer Biomet, Medtronic, and TÜV SÜD America. In these high-stakes roles, she oversaw quality audits, played a pivotal role in supporting regulatory inspections, and spearheaded the implementation of robust quality management systems.