Shivani Chhatani

Background

About Shivani Chhatani

Well-versed with ICH guidelines FDA ISO regulations and Good Clinical Practice. Experienced in vendor budget management. Setup Manage Implement and Maintenance of eTMF and ensure TMF configuration according to ICH-GCP Guidelines. Extensive experience with clinical research and strong knowledge of drug development processes. Hands on experience and knowledge in CTMS EMR EHR databases (Oracle Siebel CLIN plus IMPACT EPIC) eTMF (Veeva Vault) and paper Trial master file Experienced with Electronic Data Capture (EDC) systems including electronic CRFs and Interactive Voice Response Systems (IVRS). Data Analytics enthusiast interested in research for improved healthcare and reducing cost. Tools: Veeva Vault Figma Tableau Excel (advanced) SharePoint Greenlight Guru AWS and Asana. Skilled in creating software and firmware documentation including Traceability Matrices PFMEA SFMEA DFMEA and UFMEA with a particular focus on implantable and neuromodulation devices. Strong understanding of leads cuffs electrodes Dual header PCBA Prototypes ESD and their application in implantable medical devices and neuromodulation devices. Knowledgeable in the Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) processes ensuring quality and compliance in medical device development. Knowledge of EUMDR FDA and CDSCO medical device standards. Possess comprehensive knowledge of key industry standards and regulations including IEC 60601 (Medical Electrical Equipment) IEC 82304-1 (Health Software) IEC 62304 (Software Life Cycle Processes) IEC 62366:2020 (Usability Engineering) ISO 14971:2019 (Risk Management for Medical Devices) ISO 13485 (Quality Management Systems) ISO/TR 20416 (Post-Market Surveillance) and AAMI 24971 (Risk Management for Medical Devices) ensuring compliance and effective implementation in medical device development and production. Possess hands-on experience and strong knowledge in Phase Closure for Phase I Phase II Phase III and Phase IV of projects actively participating in the review and finalization of project deliverables and ensuring successful project completion.