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National Institute of Health and Family Welfare (NIHFW) National Institute of Health and Family Welfare (NIHFW)

10th RTP on Implementation of QMS in Medical Device

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10th RTP on Implementation of QMS in Medical Device

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  • Regulation of Medical Devices

    PDF

  • Design Control & Development aspects of Medical Devices

    PDF

  • Biocompatibility & Biological Safety Assessment of Medical Devices

    PDF

  • Regulatory Requirements for in Vitro Diagnostic Device

    PDF

  • Classification of Medical Device, IVD

    PDF

  • Clinical Investigation & Clinical Performance evaluation of Medical devices

    PDF

  • Device Master File

    PDF

  • Quality Management System for Medical Devices

    PDF

  • Essenstial Principles of safety and performance of Medical Devices & IVDs

    PDF

  • Risk Management requirements for medical devices

    PDF

  • Disciplining Manufactures Effective compliance Mechanism

    PDF

  • Materiovigilance Adverse Evenet Reporting and Analysis

    PDF

  • Regulatory Inspection Non Compliances observations

    PDF

  • Role of Standards in Quality of Medical Devices

    PDF

  • Use of Symbol and Labelling requirement for Medical Devices & IVD

    PDF

  • Soft skills

    PDF

  • Medical Device Portal

    PDF

  • Post Assessment

    Assessment

  • Certificate

    CSDCO Certificate

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This course includes

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  • Learning Content
  • Assessment
  • Discussion Forum
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For technical (platform) related queries, contact:

Nodal Officer, SAKSHAM
Dr. Dharmendra Kumar Yadav
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 225

Assistant Nodal Officer, SAKSHAM
Dr. Raj Narayan
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 327
Email - support.saksham@nihfw.org

Department of Statistics & Demography (S&D) NIHFW, New Delhi - 110067
Website : www.nihfw.org

For NMCN related queries, contact:

Dr. Avdesh Chandra
Project Consultant, National Resource Centre, National Medical College Network, AIIMS, New Delhi - 110608
Contact - +91-9910675076, +91-9818664747
Email - nrcsetfacility@aiims.edu