PhD Scholar (2024-Ongoing), AMCHSS, SCTIMST

M.Tech Quality Management, BITS Pilani, 2024

B.Tech Biotechnology, Anna University, 2011

Scientist C (Medical device Regulation), SCTIMST, Aug 2018-Till date

Junior Project Fellow, HLL Lifecare Ltd, Aug2012-Aug 2018

Medical Device Regulatory Compliance, Classification System for Medical Devices

Risk analysis for medical Device, Regulatory standards & Guidelines

Health Technology Assessment of MD & IVD

Clinical Investigation of Medical Devices & IVD

ISO 13485 Quality Management Systems for Medical device

Causality Assessment of Medical Devices & IVDs

Bureau of Indian Standards (BIS) Sectional Committee Member 1. Medical and Surgical Cardiology Equipment Sectional Committee (MHD 06) 2. MHD 10-Medical Laboratory Instruments

Implementation of ISO 13485 QMS

Licensing & Registration of medical devices with CDSCO

Identification of regulatory requirements for medical devices, Regulatory dossier preparation, risk & quality management of medical device.

Risk Analysis for Medical devices

Causality Assessment of Medical device for Materiovigilance Programme of India

IEEE Engineering in Medicine and Biology Society (EMBS)

IEEE

Lifetime membership of Material Research Society of India (MRSI)

Development of Regulatory Compliance Portal for MD & IVD, TRC Funded: as PI

Industry Collaborative Project-Development of Urinary Incontinence Device with M/s Abhaya 3CD Private Limited (Role: PI)

DBT Center of Excellence Minimally Invasive cardiovascular devices: Co-PI for Regulatory Compliance

ICMR National center for Preclinical evaluation of Cardiovascular devices: Co-PI for Regulatory compliance

Usability engineering facility to meet medical device regulatory requirements ?feasibility: Co-PI

Materiovigilance Programme of India (MvPI)-Causality Assessment of Medical Devices

Developing System Procedures for ISO 13485 QMS Implementation

Risk Analyis of Medical Devices

Commercial Manufacturing Licenses Obtained from CDSCO - Chitra EnMesh Swab (MD-5)- Chitra Embed Swab (MD-5) -Chitra VTM (MD-5)

Test Manufacturing License-IgG/IgM Antibody Detection Kit, PLGC-FIBHA

Institute Registeration in CDSCO SUGAM Portal

Clinical Trial License-UTI Detection Kit

Medical Device Testing Laboratory-Submission for certification to CDSCO & Inspection Assistance

12 Years of Experience in Medical Device-Regulation & standards Compliance, Clinical Research Regulation

ISO 13485 Awareness training by QMART

Package Validation for medical devices, Indian institute of Packaging, Indian Institute of Packaging

Laboratory System & Internal Audit as per ISO/IEC 17025:2017 from Quality Council of India

ISO 13485 Implementation Training conducted by BSI Group

Data science Using R_SCTIMST

General awareness programme on Laboratory quality management system ISO 17025:2017

Biological Evaluation as per ISO 10993

Health technology Assessment of Medical Device

Post-market surveillance

Member of ISO 13485 implementation group.

Member Materiovigilance Programme of India, IPC Ghaziabad

Member of ICMR Covid-19 product evaluation committee

Mr. D. S. Nagesh, Scientist 'G' (Senior Grade) & Scientist-in-Charge
Mr. Vinod Kumar V, Engineer 'F'
Mr. Sarath S. Nair, Engineer 'D'
Ms. Sreedevi. V, Tech. Asst.

Regulating Software as Medical Device (SaMD): A Comprehensive Overview of The International Medical Device Regulators Forum (IMDRF) Framework and Gap Analysis of Indian Medical Devices Rules, 2017, IEEE International conference on Emerging Technologies and Intelligent System, 2025.

Adverse Event Analysis -widely used Scale and Methods in the Five-Days Training Programme on Medical Device Regulation" at Bhutan Food and Drug Authority (BFDA), Bhutan on 29th Feb 2024

Speaker for National Conference on management and ensuring safety of medical devices at NIMHANS, Bangalore

" Medical Device Rules, 2017" at CSIR-CSIO, Ministry of External Affairs, New Delhi

"Regulatory framework of medical device in India" at startup winc 2020

" Indian Medical Device Regulation & Importance of MvPI" at International conference on current regulations for Medical devices and IVDs organized by AICTE & JSS college, Ooty

" Causality Assessment of Medical devices and IVD" at Indian Pharmacopoeia Commission (IPC), Ghaziabad, organized by NCC-MvPI and AMTZ, Hyderabad

" Causality Assessment of Medical devices" at Govt. Medical College, Jammu

"Causality Assessment of Medical Devices" at 3rd,4th, 6th Induction cum training programme by Indian Pharmacopoeia Commission (IPC), Ghaziabad

"Regulatory framework for MD & IVD in India" at TIMED, SCTIMST

"Standards for regulatory compliance" medical devices & biomaterials" organized by IIPC, SCTIMST

" Medical Device Development-From Concept to Commercialization" at Mar Baselios college of Engineering & Technology, Trivandrum

"Writing project proposals for medical device development: Understanding your regulatory obligations", CDC, SCTIMST

"Causality Assessment: Medical Devices and IVDs" in CME cum e workshop on materiovigilance ensuring safety of medical device, organized by AIIMS, Patna

"Indian Regulatory framework & Importance of MvPI", Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore

M.Tech Dissertation project-Mr. Harsh Sah, School of Bioscience, Apeejay Stya University, Gurgaon, Haryana-from 01/07/2024-30/06/2025