Certificate in Regulatory Affairs for IVDs

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The Certificate in Regulatory Affairs for IVDs is a comprehensive course that equips learners with critical skills needed in the rapidly evolving In Vitro Diagnostic (IVD) industry. This program emphasizes the importance of regulatory compliance, ensuring the safety and efficacy of IVD devices.

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AboutThisCourse

With the increasing demand for IVDs in healthcare, professionals with a deep understanding of regulatory affairs are in high demand. This course provides learners with the essential knowledge to navigate complex regulatory landscapes, ensuring the successful market approval and commercialization of IVD products. Through hands-on training and expert instruction, learners will develop skills in regulatory strategy, quality management, clinical trials, and submission of regulatory applications. By completing this course, learners will be well-prepared to excel in regulatory affairs roles, driving innovation and growth in the IVD industry.

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CourseDetails

• Regulatory Foundations for IVDs: Understanding the Legal Landscape 
• IVD Classification: Defining the Risk and Regulatory Requirements 
• Quality Management Systems: Implementing ISO 13485 for IVDs
• Clinical Evidence: Designing and Conducting Clinical Studies for IVDs
• Labeling and Instructions for Use: Ensuring Compliance with FDA and EU Regulations
• Pre-market Notification (510(k)): Navigating the FDA Submission Process for IVDs
• European Union (EU) Regulatory Affairs: Mastering the In Vitro Diagnostic Medical Device Regulation (IVDR) and Conformité Européene (CE) Marking
• Post-market Surveillance: Managing Adverse Event Reporting and Post-market Clinical Follow-up for IVDs
• Global Harmonization: Exploring International Regulatory Standards for IVDs

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EntryRequirements

  • BasicUnderstandingSubject
  • ProficiencyEnglish
  • ComputerInternetAccess
  • BasicComputerSkills
  • DedicationCompleteCourse

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  • NotAccreditedRecognized
  • NotRegulatedAuthorized
  • ComplementaryFormalQualifications

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CourseFee

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FastTrack GBP £149
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AcceleratedLearningPath
  • ThreeFourHoursPerWeek
  • EarlyCertificateDelivery
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StandardMode GBP £99
CompleteInTwoMonths
FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • FullCourseAccess
  • DigitalCertificate
  • CourseMaterials
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CERTIFICATE IN REGULATORY AFFAIRS FOR IVDS
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UK School of Management (UKSM)
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05 May 2025
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