Artemis Ailianou, PhD, MBA is a regulatory affairs consultant specializing in US FDA and EU MDR regulatory submissions. She is a project manager and technical writer, developing regulatory submissions for medical devices, including CE marking, US IDE, EU clinical trial applications, and annual progress reports. Her services include creation of technical documentation and design dossiers for high-risk implantable devices; QA/RA engineering; and MDD to MDR transitions. Dr. Ailianou also works in Quality Management Systems and Risk Management, developing, reviewing, optimizing post-market procedures and leading internal compliance audits to prepare companies for official regulatory audits. She helps companies ensure their QMS and Risk Management systems comply with ISO 13485, ISO 14155, ISO 14971, and EU MDR regulations. Dr. Ailianou earned her Bachelor of Science in Chemical Engineering from the University of Texas, Austin; her PhD, also in Chemical Engineering, from California Institute of Technology; and her MBA from INSEAD in France.
Regulatory Pathways Group Inc.
a California corporation
Inquiries and general information:
info@regulatorypathways.com
