Masterclass Certificate in IVD Regulatory Affairs Documentation Essentials

Name: Masterclass Certificate in IVD Regulatory Affairs Documentation Essentials
Price: 149 GBP
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The Masterclass Certificate in IVD Regulatory Affairs Documentation Essentials is a comprehensive course that equips learners with critical skills in the regulatory documentation of In Vitro Diagnostic (IVD) devices. This course is crucial in the context of the rapidly evolving IVD industry, where compliance with complex regulatory requirements is paramount.

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AboutThisCourse

This course is designed to meet the increasing industry demand for professionals who can navigate the intricate regulatory landscape of IVD devices. Learners will gain a deep understanding of the essential documents required for IVD registration, including the Design History File, Technical File, and Summary Technical Document. By the end of this course, learners will be able to prepare and submit comprehensive regulatory documentation for IVD devices, thereby enhancing their career prospects in this growing field. This course is an excellent opportunity for professionals seeking to advance their careers in regulatory affairs, quality assurance, or IVD device development.

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CourseDetails

• IVD Regulatory Affairs Overview
• Understanding IVD Directives and Regulations
• Essentials of IVD Documentation: Designing and Developing
• IVD Labeling and Instructions for Use
• Clinical Evidence and Performance Evaluation Reports
• Quality Management System for IVDs
• Post-Market Surveillance and Vigilance
• IVD Regulatory Submissions and Approvals
• Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF)

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EntryRequirements

BasicUnderstandingSubject
ProficiencyEnglish
ComputerInternetAccess
BasicComputerSkills
DedicationCompleteCourse

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FastTrack GBP £149

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AcceleratedLearningPath

ThreeFourHoursPerWeek
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StandardMode GBP £99

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TwoThreeHoursPerWeek
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MASTERCLASS CERTIFICATE IN IVD REGULATORY AFFAIRS DOCUMENTATION ESSENTIALS

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UK School of Management (UKSM)

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05 May 2025

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