Immunomatics Recruits Medical Device Regulatory Expert Stephanie Rallis-Daw to Support SaMD Regulatory Strategy
Medical device regulatory and quality expert joins Immunomatics as the company prepares to advance its AI-powered transplant donor-recipient risk assessment technology toward clinical use.
SAN MARCOS, CA (September 21, 2026) Immunomatics, Inc., a health technology company developing artificial intelligence-based tools to improve transplant donor risk assessment, today announced that it has recruited Stephanie Rallis-Daw, RAC, CQE, CMDA, to provide regulatory advisory and consulting services for the company’s Software as a Medical Device (SaMD) development program.
Rallis-Daw brings more than 20 years of experience in medical device quality systems, regulatory compliance, risk management, design controls, verification and validation, and regulatory strategy. Through her work with medical device companies and other regulated organizations, she has supported product development and quality programs throughout the medical device lifecycle.
At Immunomatics, Rallis-Daw will advise and support the company on the regulatory and quality framework required to advance its technology from research and clinical validation to a regulated Software as a Medical Device (SaMD), including activities to prepare Immunomatics for future interactions with regulatory authorities.
“Recruiting Stephanie is an important step in building Immunomatics into a Software as a Medical Device company,” said Lidio Meireles, PhD, Founder and CEO of Immunomatics.
The company’s research has received funding through a National Institutes of Health Small Business Innovation Research (NIH SBIR) Phase I award, supporting the development of its approach to assessing HLA compatibility risk.
“As we move toward larger-scale clinical validation, it is essential that regulatory strategy and product development evolve together, rather than treating regulatory requirements as something to address later,” Meireles added. “Stephanie will help us embed that discipline into Immunomatics from the beginning.”
Rallis-Daw is President and CEO of Rallis-Daw Consulting LLC, which provides regulatory and quality consulting services to medical-device and life-sciences organizations. She holds the Regulatory Affairs Certification for medical devices, along with certifications in quality engineering and medical-device auditing.
Her engagement strengthens Immunomatics’ growing network of scientific, clinical, regulatory, and industry experts who support the company as it works toward its long- term objective of bringing AI-based transplant risk assessment into clinical practice.
About Immunomatics
Immunomatics, Inc. is a San Diego County-based healthtech company developing AI-powered tools to improve transplant outcomes by optimizing donor selection. Founded by Lidio Meireles, PhD, a blood stem cell transplant survivor and computational biologist, the company is building predictive models that use advanced machine learning and HLA compatibility modeling to estimate the risks of different donor-patient combinations. For more information, visit Immunomatics.com.
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