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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

पाठ्यक्रम के बारे में

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कोई प्रशिक्षक नहीं

  • 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 (ISO 13485) 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

  • Standard Quality requirements

    PDF

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

    PDF

  • Soft skills

    PDF

  • Online Portal for Medical Device

    PDF

  • Post Assessment

    Assessment

  • Certificate

    CSDCO Certificate

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इस पाठ्यक्रम में शामिल है

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  • Assessment
  • Certificate

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तकनीकी (प्लेटफ़ॉर्म) संबंधी प्रश्नों के लिए संपर्क करें

Nodal Officer, SAKSHAM
Dr. Dharmendra Kumar Yadav
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 225
Email - support.saksham@nihfw.org

Address

H52G+C6X, Baba Gang Nath Marg, Block A, Munirka, New Delhi, Delhi 110067
Website : www.nihfw.org

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