Phebe George Email & Phone Number

Thiruvananthapuram, Kl, In

Kerala, India

-Applications to CDSCO for manufacturing and conducting clinical trials of medical device -Managed applications of MD-3, MD-12, MD-22 to CDSCO -Formulated technical documentations for CDSCO applications -Prepared risk management files for medical devices according to ISO 14971 standards -Lead the regulatory affairs team in assigning tasks to design and draft documents for licensing authorities - Assisted in drafting and maintaining ISO 13485:2016 standard documentation -Technical Coordinator for Margin delineation in Neuro Oncology using tissue diffuse reflectance and auto fluorescence imaging study in collaboration with dept of neuro surgery, SCTIMST-Principal investigator for clinical validation of non-invasive bimodal imaging device for Uterine Cervical cancer detection and biopsy guidance -Patient recruitment, trial monitoring, data analysis, record maintenance in collaboration with Kasturba Medical College, Manipal and Govt Medical College , Thiruvananthapuram. -Assembly and in-house testing of optoelectronic medical devices for Oral and Cervical cancer detection-Investigator for pilot clinical study to detect margin in breast cancer surgery using diffuse reflectance spectroscopy in collaboration with Manipal Academy of Higher Education. -Technical assistance to surgeons and pathologist for conducting the trial, measuring the spectrum of each specimens ex vivo, data analysis and records.-Co-investigator for diffuse reflectance and fluorescence based imaging studies on ex-vivo breast cancer specimens for margin detection-Co-Investigator for gastro intestinal luminal pathology margin detection based on oxyhaemoglobin's

Kerala, India

-Responsible for Regulatory affairs of Medical Devices -Formulated technical documentations for CDSCO applications -Conducted literature review, prepared proposals for biomedical research -Conducted research and implemented new techniques for medical instrumentation. -Assisted in drafting and maintaining ISO 13485:2016 standard documentation -Designed and led clinical study to assess the accuracy of handheld multispectral imaging device for cervical cancer detection -Collaborated with surgeons and pathologists to conduct Pilot Clinical Trials for non-invasive surgical margin detection using bimodal imaging techniques -Hardware Assembly & Testing of non-invasive medical devices for oral and cervical cancer detection-Optical Liquid phantoms based on H0267 -Development and Evaluation-Electronic Circuit Designing-Preparation of BOM-Earned the National Bio Entrepreneurship Competition 2020 award for CerviScan device under mother and child category

Kerala, India

Post Graduate Academic Project: Non-invasive Detection of Cervical Cancer using Diffuse Reflectance and Fluorescence Imaging~Assembled and tested prototype of medical device for cervical cancer screening ~Measurement of LED spectrums using Spectra suite software ~Questionnaire survey to assess the knowledge about cervical cancer and its screening methods~Meetings with gynaecologist for association in clinical trial and to understand the clinical requirements ~Prepared clinical protocols for evaluation and testing of medical device ~Presentations before Review board and Ethics committees

Master Of Technology - M.Tech, Biomedical Engineering

Academic Project- Non Invasive Detection of Cervical Cancer using Diffuse Reflectance and Fluorescence Imaging This study envisaged.

Bachelor Of Technology (B.Tech.), Electronics And Instrumentation

Academic Project: Silicon Cochlea System with Biologically Faithful Response- Simulation of silicon cochlea was developed with the help.