Sethukrishna Prajeesh

Works with GRK2247(Advanced Medical Physics in Image-Guided Cancer Therapy) project to build a small animal cone beam clinical CT.

• Assisted with the creation and maintenance of a product file that demonstrates product conformity with international standards and regulations, including ISO 13485, ISO 14971, ISO 62304, FDA Quality System Regulation (QSR), and European Union Medical Device Regulation (MDR). • Demonstrated in-depth knowledge of regulatory standards and medical device regulations to ensure compliance and provide recommendations.

• Developed standard operating procedures for the phantom production process to ensure consistent and accurate material composition. • Tested material used in each phantom batch to ensure quality and consistency. • Acquired phantom images using the MSOT Acuity Echo system to quantify image quality characteristics. • Prepared regulatory-compliant documentation to ensure compliance with relevant standards.