Candace Cederman is a Principal Consultant at CardioMed Device Consultants with more than 30 years of experience in medical device regulatory affairs, quality assurance, and regulatory compliance. A former FDA/CDRH engineer and FDA field investigator, she brings a unique combination of regulatory, technical, and industry expertise to help medical device manufacturers navigate FDA requirements, obtain regulatory clearances, establish effective quality management systems, and address complex compliance challenges.
Experience
Ms. Cederman has extensive experience developing regulatory strategies and securing marketing clearances for a broad range of medical devices in the United States and international markets. Her expertise includes FDA regulatory submissions, quality management systems, Good Manufacturing Practice (GMP) requirements, ISO standards, and European regulatory requirements.
During her career, she has served as an FDA/CDRH engineer, FDA field investigator, medical device industry manager, and independent regulatory consultant. She has led and supported FDA inspections, regulatory compliance assessments, product recalls, and the development and implementation of GMP- and ISO-compliant quality systems.
At CardioMed, Ms. Cederman advises manufacturers on FDA regulatory compliance, quality system development and remediation, inspection readiness, and responses to regulatory findings. She also supports companies pursuing ISO certification and European market access. She is particularly skilled at translating complex technical and regulatory requirements into clear, practical recommendations.