Services and expertise
Experience-driven consulting that helps organizations build stronger quality systems and navigate regulatory requirements with confidence.
What we do
We provide targeted, collaborative support tailored to the specific needs of medical device manufacturers and cleanroom teams.
Development, implementation, and continuous improvement of electronic and paper-based quality systems aligned with ISO 13485, 21 CFR 820, and the Quality Management System Regulation (QMSR). Includes process mapping, procedure development, and system effectiveness reviews.
Guidance on regulatory pathways, technical documentation, design controls, risk management (ISO 14971), and preparation for submissions or inspections. We help translate requirements into practical operational processes.
Comprehensive reviews of current systems against applicable standards and regulations. Identification of gaps, prioritization of corrective actions, and support preparing teams and documentation for internal, customer, or regulatory audits.
Customized training programs and coaching that strengthen quality awareness, ownership, and decision-making across the organization, from leadership to operators.
Focused assistance for teams establishing and maintaining ISO 7 and ISO 8 cleanrooms, including environmental controls, monitoring, and documentation.
Practical guidance for emerging companies establishing their first quality systems, as well as support for established organizations scaling operations or entering new markets.
The principal
Owner and principal consultant
Celina is an analytical quality leader with more than 20 years of experience in product design and process quality within the medical device industry. She specializes in electronic quality management systems (eQMS) and has deep expertise in the requirements of 21 CFR 820, the evolving Quality Management System Regulation (QMSR), and ISO 13485.
Her background includes progressive roles supporting quality systems at established medical technology organizations. She holds a degree from the University of Michigan and is bilingual in English and Spanish. Based in the Detroit Metro, Michigan, Celina founded Compliance Care Consulting LLC to serve customers nationwide with practical, high-impact consulting that helps clients strengthen their quality culture and achieve sustainable regulatory compliance.
Clients value her collaborative approach, ability to translate complex requirements into workable processes, and focus on building internal capability rather than dependency.