Prithul Bom serves as the CEO and Technical Reviewer at Regulatory Technology Services (RTS) the FDA accredited Third Party Review Organization. Prithul has 22 years of healthcare, medical device, biotech and IVD industry experience, starting with her career as a bioinformatics software developer in 1998 at Lawson Software, Infor. In addition to software development, Prithul has served in Business Development (Johnson & Johnson), Scientific Affairs and Global Head of Regulatory Affairs (Chiltern), and Executive Strategist (Covance, Labcorp). Prithul's experience includes managing regulatory scientists in Asia, Europe and North America, 510(k), IDE, de novo, and Q-submissions, clinical development planning, protocol development, pre-IND and IDE meetings and Phase I-IV clinical study operations as the Executive Lead. Most of Prithul's specific scientific and regulatory experience since 2013 has been in imaging diagnostic drugs and biologics, software and hardware medical devices such as contrast agents, radionuclides, MR, PET, SPECT, CT, Ultrasound, EEG, ECG and Near Infrared imaging modalities and some electrosurgery devices and accessories.
Regulatory Technology Services: https://www.rts3pro.com/
Third Party Review Organization: https://www.fda.gov/medical-devices/premarket-submissions/510k-third-party-review-program?utm_campaign=2019-08-01%20CDRH%20New&utm_medium=email&utm_source=Eloqua