Avinash Murugan

Experience

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  Apollo Multispeciality Hospitals

  Jun 2015 - Jul 2015

  Quality Assurance Intern

  An overview of the various departments in the hospital. Various devices under each department were studied in general.Devices covered:X-rayMRIVentilatorDefibrillatorInfusion pumpSyringe pumpLithotripterSpirometer (PFT) Lab Visits:Cath labHistopathology and cytology labEcho lab

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  KS HOSPITALS

  Jun 2016 - Jul 2016

  Engineering Intern

  Modalities covered: Imaging and DiagnosticsEquipments studied under Imaging: Analog mammographyDigital mammographyDEXAUltrasoundDigital X-rayStereotactic biopsyEquipments studied under Diagnostics:Automated ColorimeterCLIAEliteComplete Blood Counter (CBC)Fully automated Colorimeter

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  Bio yantra'16

  Aug 2016 - Aug 2016

  Engineering Intern

  A three day experience as a Commitee Head at BIOYANTRA was a truly unique and enriching one. The expo included exhibits of varied medical equipments from companies around the world. Seminars and lectures on state of the art healthcare trends were also a part of the event. The most vital of all was the Bio yantra interoperability event which is based on the interoperable sharing of medical data between different platforms. I was able to interact with professionals from the industry and gain insight on the various healthcare technologies. Show less

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  Prashanth Hospital - India

  Jul 2019 - Aug 2019

  Research Intern

  In this internship I studied about various working measures of ventillator machines, syringe pumps and working of endoscopy.

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  Tata Elxsi

  Feb 2021 - Dec 2023

  Senior engineer Medical Devices Grade E (SCIENTIST)

  Experienced in Regulatory compliance of MDR 2017|745 for Class III, Ilb, Ila, I of Renal Disposables & Solutions, Urology devices, Anesthesia devices and Cardiac Rhythm products.Preparation and review of General Safety Performance Requirement (GSPR), Summary of Technical Documentation (STED) for the Regulatory submission.Experience in International submission dossier preparation and coordination with different stake holders.Experience in the preparation and review of Technical documentation like, Design Input requirements, Design output, Design V&V Protocol, Design V&V Report, Traceability matrix, Human Factors summary and evaluation, Special/Rationale report.Experience in Creation and review of Risk management files like, Risk Management plan, DFMEA, UFMEA and Risk Management report. Show less

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  Stryker

  Dec 2023 - Jan 2025

  Regulatory Affairs Specialist

  Market Access:Leading Market Access Team for International Product Registration of HIP and KNEE Replacement products (Both Implants and Instruments)excluding EU and USA.Collection of documents from MultipleElectronic (PLM) Tools and SME from every function for First Time Registration of JR products.Responsible for Deficiency Requests for the products submitted to the Regulatory Body (Health Authority).Providing response to Deficiency questions by connecting to appropriate SMEs to understand, draft and review the response.Corporate Project:Preparation and publishing of RA Monthly Highlights.Handled International Change Notification and International Regulatory Notification process to international design and regulatory division.Prepared PPT's with Divisional RA Team for International RA Knowledge Center and released it in Stryker LMS portal.Skills: US FDA • Medical Device Regulation(MDR) • Classification • Product Registration Show less

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  Hexaware Technologies

  Jan 2025 - now

  Regulatory Affairs Specialist

  Market Access:Leading Research & Development and Registration of Medical devices as a New product development Access Team for International Product Registration of HIP and KNEE Replacement as well as Robotics surgical products (Both Implants and Instruments) including EU and USA.Collection of documents from Multiple Electronic (PLM) Tools such as Enovia, MAP Agile for designing devices and SME from every function for First Time Registration of Implant products.Responsible for Deficiency Requests for the products submitted to the Regulatory Body and Health Ministries of Geographies around the world (Health Authority).Providing response to Deficiency questions by connecting to appropriate SMEs to understand, draft and review the response related to Designing of medical devices.Corporate Project:Preparation and publishing of RA Monthly Highlights.Handled International Change Notification and International Regulatory Notification process to international design and regulatory division.Prepared PPT's with Divisional RA Team for International RA Knowledge Center and released it in HEXAWARE LMS portal. Show less