Ms. Amrutha C.
Scientist 'C'
Phone : +91-9995960774 (Mobile)

M.Tech Quality Management, BITS Pilani

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

ISO 13485 Quality Management Systems for Medical device

Causality Assessment of Medical Devices & IVDs

Licensing & Registration of medical devices with CDSCO

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

Implementation of ISO 13485 QMS

Risk Analysis for Medical devices

Causality Assessment of Medical device for Materiovigilance Programme of India

IEEE Engineering in Medicine and Biology Society (EMBS)


Lifetime membership of Material Research Society of India (MRSI)

Industry Collobatorative Project-Development of Urinary Incontinece Device with M/s Abhaya 3CD Private Limited

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

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

Risk analysis as per ISO 14971

Package validation for medical devices

ISO 13485 Implementation Training conducted by BSI Group

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

Biological Evaluation as per ISO 10993

Member of ISO 13485 implementation group.

Nodal officer for regulatory compliance portal, DST.

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.

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


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,
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,

Book Chapter

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,