Yuti Modi

WORK HISTORY

EDUCATION

ABOUT YUTI MODI

Yuti is a Quality Management Systems Lead. She holds a Master of Biotechnology from The University of Queensland. She works with Physical Medical Device IVDs as well as Software Medical Devices (SaaS). She advocates Continuous Improvement and has experience in building internal tools and processes to drive improvement. Yuti has gained extensive experience in preparing the company for certification/accreditation against international standards (ISO 13485, ISO 15189) whilst being compliant to ISO 14971, IEC 62304 and ISO 27001. As the QMR, has led external audits, conducted internal audits, done technical writing of SOPs, acted as the Document Controller, as well as drive RCA for CAPAs. She holds extensive experience with Regulatory Affairs in that she prepared the company for IVD medical device registration in Australia with the TGA, EMA in the EU, MHRA in the U.K and FDA in the U.S. This included preparing Device Technical Documentation, being compliant to FDA 21 CFR Part 820, HIPAA compliance and IVDD/IVDR regulations. Yuti has a passion for bringing together different groups and disciplines to implement organizational wide changes. She has acted as the student representative for the Equity, Diversity and Inclusion committee at The University of Queensland. Apart from her profession in Quality, Yuti is passionate about Table Tennis, Trying/Cooking different cuisines and Astrophotography.