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Home Pharma Courses Technical File for Saudi Regulation for Medical Devices
New Approach of Process Validation SAR  5,520
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Qualified Person for Pharmacovigilance QPPV SAR  3,800
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Technical File for Saudi Regulation for Medical Devices

SAR  3,000

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Category: Pharma Courses
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Description

Course Outlines

  • Scope of the Law and Assessment, Medical Device Definitions, & The State of the Art.
  • Identifying Devices, Combination Products, & Borderline Devices.
  • Classification, Rules for Classification, & Guidance.
  • Subcontractors, & Device Specification for Technical File.
  • Essential Principles, Checklist, Verification and Validation, & Evidence Required.
  • Risk Analysis, Relation to ISO 14971, Hazard Analysis, & Risk Analysis.
  • Clinical Evaluation, Clinical, Evaluation Plan, Equivalence, & Essential Principles Met.
  • Literature review, Clinical Evaluation Report, Labelling and instructions for use, & Design and Manufacturing.
  • Declaration of Conformity, Post-Market Surveillance, & Post-Market Clinical Follow-Up.
  • Periodic Safety Update Report, Summary of Safety and Clinical Performance, & Vigilance.
Additional information
Date

30 June 18-20 May, 2021

Location

Online

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  • Email
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