Vidya Sagar

Background

About Vidya Sagar

Dr Vidya Sagar, PhD, PDF,PG - AI / ML, MBA (AI) DAS (Biostatistics) PROFESSIONAL DIGEST Chief Scientist, Head QA /RA, AI / ML Professional, Lead auditor, SME - of reputed Medical Device companies with 17 years of extensive experience in product development, regulatory, clinical submissions, outsourcing, compliance, quality control /assurance Decisive leader with a proven track record in a fast-paced, highly competitive environment & a passion for innovation and teamwork that delivers successful solutions to complex projects & drives growth, productivity, & reduced costs. Experienced in NPD, Invitro testing, and Preclinical/Clinical studies including documentation for regulatory submissions / DHF, DMR, D&D Conscientious professional with experience in R&D, NPD, QC, QA, & RA in Medical Device Industry. Prepared Device Master Files (DMF) as per DCGI/FDA/EUMDR requirements for submission to NBs Involved in the development, patenting, documentation, submission, & approvals of five Class II & Class Medical devices Submitted DMFs for seven new Class Medical devices for EU ( MDD/MDR) & ANVISA, three Devices for 510K Lead Auditor QMS 13485: 2016 and Team lead for MDSAP and Stage 1 & 2 audit certification. Lead in conducting BE studies(ISO 10993: 2018) and Animal studies (CGMP/CPSEA / for various classes of Devices in India and abroad Experienced in conducting clinical trials for Phase II, Phase and PMS / PMCF, Registries for Class II and Class Devices. Conducted Phase and PMS / PMCF for 6 Devices as per MED2.7.1 guidelines for submission to IMDR / EU MDR/ PMA Decision making for invitro engineering studies for a different class of Medical Devices, Responsible for product complaint handling with RCA and CAPA and Rejection analysis Extensive systems-level experience in technology development, Program/Project Management, Risk Management ( 14971:2019) Risk Analysis.Utilize excellent collaborative skills to achieve the most from people and technology Expertise brings a tremendous appreciation of effective FDA QSR, ISO13485 QMS, and application to all projects with a High-level understanding of MDD, MDR, and MDSAP Technical Reviewer of documentation for MDSAP countries (TGA, Australia), HC,(Canada), FDA (US), ANVISA (Brazil), PMDA (Japan) Specialized in Biostatistics, SPC, Six sigma, CP, PP and CPk, PPC, & Software validation linked to Artificial Intelligence and Machine Learning. 5 International Patents, 45 International / 25 National publications. Awarded 15 PhDs and 45 M Pharmacy Projects, 2 BIRAC projects