Dr. Ailianou combines scientific rigor, regulatory acumen, and a knack for transforming complex data into actionable strategies to help you navigate the world of medical device regulation and quality assurance.  Dr. Ailianou is dedicated to driving innovation and ensuring compliance in the ever-evolving regulatory landscape.

Experience and training

• Design dossiers for CE marking under EU MDR for high risk implantable devices: assembly and submission
• Preparation and submission of US IDE applications, supplements and annual progress reports
• Technical writing: device technical documentation, risk management reports, SOP
• ISO 14155:2020 – Good Clinical Practices. Clinical investigation applications for Canada, UK, Germany, Switzerland
• ISO 14971:2019 – Risk management: design, manufacturing, and usability risk analysis
• ISO 13485:2016 – Quality management systems – requirements for regulatory purposes: internal auditor
• Regulatory compliance of QMS under EU MDR
• Languages: English, French, Greek

Education

• Master in Business Administration, INSEAD, France
• Ph.D. in Chemical Engineering, California Institute of Technology, California, USA
• B.Sc. in Chemical Engineering, University of Texas at Austin, Texas, USA