Strategically Strong, yet Tactically Sharp

Rallis-Daw Consulting LLC is a woman owned business located in San Clemente, CA offering a wide array of services to the life sciences industry including but not limited to full quality management system implementation (QMS/eQMS), gap analyses and remediation, technical writing, regulatory submissions, program management, organizational training, mentoring and women empowerment initiatives.

Meet the Core Team

President & CEO

Stephanie Rallis-Daw is the President and CEO at Rallis-Daw Consulting LLC. Stephanie has over two (2) decades of experience in the highly regulated life science industry. She holds a Bachelor of Science in Biology emphasis Pre-Medicine from The Master's University (Santa Clarita, CA), currently works for a Notified Body as a lead auditor and technical documentation reviewer and holds the following industry recognized certifications:

Exemplar Global Certified Medical Device Lead Auditor (EU 2017/745, European Union Medical Device Regulation (EU MDR), ISO 13485:2016 and Regulatory Compliance Audit)
American Society of Quality (ASQ) Certified Quality Engineer (CQE)
ASQ Certified Medical Device Auditor (CMDA)
MDSAP Training as part of employment with Notified Body (40+ hours completed in 2023-2025)
ISO 14971:2019 Training as part of employment with Notified Body (12+ hours completed in 2023-2025)
Regulatory Affairs Professionals Society (RAPS) Regulatory Affairs Certification (RAC) Devices
Zschool Mentor Pro Certification

In her free time she enjoys walks on the beach and family time.

Senior Manager of Business Operations

Dana Pembroke is the Office Manager at Rallis-Daw Consulting. Dana has over 15 years of experience in marketing and office management. She holds a Bachelor of Fine Arts in Human Development from California State University, Long Beach. Dana, a native to Southern California, is married and has two children. In her free time she enjoys traveling, photography, hot yoga and cooking.

Quality System Manager

Sonia C. Loya is the Quality System Manager at Rallis-Daw Consulting, LLC. and is a certified Quality Improvements Associate. Sonia has over 15 years of progressive experience in Quality Systems, process improvement, quality compliance, and product development initiatives. Sonia is a contributor at the Rallis-Daw Consulting, LLC. where she will support eQMS integration and implementation with the intention of empowering customers to achieve governance and compliance. Sonia is a lifelong resident of San Juan Capistrano, California, where she resides with her husband and five children. During her free time, she enjoys cheering on her children as they compete in sports and or enjoys reading a romantic novel.

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Quality Engineering Manager

Thai-An Dao (pronounced "tie" "ann") is the Quality Engineering Manager at Rallis-Daw Consulting, LLC. She has been working in the medical device industry since 2010 in various roles throughout Quality and Supply Chain, for example quality system management (including risk management), manufacturing quality, supplier quality and technical sourcing. Thai-An holds a Bachelor of Science in Biomedical Engineering from the University of California, Irvine and has attained:

DEKRA Certificate of Lead Auditor Training for ISO 13485:2016 Medical Device (Certificate No: MD3121, AU8818, TL5956)

She is married with two kids, so outside of family time, she enjoys listening to music, being at the beach, swimming, trying new foods, and going on adventures.

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PROFESSIONAL AFFILIATIONS

American Society of Quality (ASQ)
Society of Women Engineers (SWE)
Association of Clinical Research Professionals (ACRP)
Regulatory Affairs Professional (RAPS)
Orange County Regulatory Affairs (OCRA)
Device Alliance
International Society of Female Professionals
San Clemente Chamber of Commerce
MedtechWOMEN

Strategically Strong, yet Tactically Sharp

Meet the Core Team

Our Partners