Prashanthi Kola

Background

About Prashanthi Kola

As a Sr Principal Engineer at Viatris, I lead the implementation of best practices for compliance requirements with respect to safety and efficacy of medical devices. I apply my extensive experience in ISO 14971:2019, FDA, EU MDR, and EU MDD standards, as well as my skills in conducting risk assessments and evaluations for various products and processes. With the help of my team, I have successfully delivered high-quality and safe solutions that meet customer and regulatory expectations. I have a strong technical background in materials science, thin film technology, vacuum deposition, and materials characterization, which I acquired through my Ph.D. from Dublin City University, and my undergraduate and postgraduate degrees from Trinity College Dublin and Institute of Technology, Tallaght. I also have multiple certifications and publications in the fields of pharmaceutical and medical device manufacture, quality auditing, and process improvement. I am passionate about enhancing my knowledge and expertise, and sharing it with others through training and consultancy.