Ms. Amrutha C.

Academic Qualifications

• PhD Scholar (2024-Ongoing), AMCHSS, SCTIMST
• M.Tech Quality Management, BITS Pilani, 2024
• B.Tech Biotechnology, Anna University, 2011

Professional Record

• Scientist C (Medical device Regulation), SCTIMST, Aug 2018-Till date
• Junior Project Fellow, HLL Lifecare Ltd, Aug2012-Aug 2018

Area of Interest

• 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

Current Activities

• 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

Membership

• IEEE Engineering in Medicine and Biology Society (EMBS)
• IEEE
• Lifetime membership of Material Research Society of India (MRSI)

On-going Projects

• 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
• Materiovigilance Programme of India (MvPI)-Causality Assessment of Medical Devices
• Usability engineering facility to meet medical device regulatory requirements –feasibility: Co-PI
• Developing System Procedures for ISO 13485 QMS Implementation
• Risk Analyis of Medical Devices

Projects Completed

• 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

Professional Experience

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

Training

• 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

अनुसंधान

• Health technology Assessment of Medical Device
• Post-market surveillance

Organisational Activities

• Member of ISO 13485 implementation group.
• Member Materiovigilance Programme of India, IPC Ghaziabad
• Member of ICMR Covid-19 product evaluation committee

Team

• 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.
  

Presentations

• 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.

Invited talks

• 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

Dissertations Supervised - M.Tech

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

प्रकाशन

Article

1. Manoj,G; Amrutha, C; Rajmohan,G; Sunil, Bhaskar; Rajeev, A; Abi Santhosh, Aprem;, A feedback survey on the clinical performance and acceptability of levonorgestrel releasing intrauterine system (EMILY?) during two years of usage., International Journal of Scientific Reports, 2018, 4(7); 186-191, http://www.sci-rep.com/index.php/scirep/article/view/444
2. Rajmohan,Gopimohan; Amrutha, Chandran; Joyce, Jacob; Sunil, Bhaskar; Rajeev, Aravindhakshan; Abi S, Aprem;, A clinical study assessing the efficacy of a new variant of the levonorgestrel intrauterine system for abnormal uterine bleeding., International Journal of Gynecology and Obstetrics, 2015, 129; 114-117, https://www.ncbi.nlm.nih.gov/pubmed/25704255

Book Chapter

1. Chandran, A., Nair, R.P., Bhatt, A. , Regulatory Requirements for the Efficacy/Safety Assessment of Cosmetics/Nano-Cosmetics Products: Opportunities and Challenges for New Approach and Methodologies., . In: Dwivedi, A., Pant, A.B., Poojan, S., Kotak, M., Tripathi, A. (eds) Hair Care Products. Springer, Singapore., 2024,
2. Vinod Kumar V, Amrutha C, Nagesh D S, Overview of Medical device development, Biomedical Product and Materials Evaluation, Standards and Ethics, 2021, Woodhead Publishing Series in Biomaterials, Elsevier 1st Edition ISBN: 978-0-12-823966-7 (print), IS, https://www.sciencedirect.com/science/article/pii/B978012823966700013X

Conference proceedings

1. Harsh Sah, Mahima Ramesh, Amrutha C*, 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 Emerging Technologies & Intelligent systems, 2025,