Executive Development Programme in IVD Regulatory Documentation

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The Executive Development Programme in IVD Regulatory Documentation is a crucial certificate course for professionals seeking expertise in the rapidly evolving In Vitro Diagnostic (IVD) industry. This programme emphasizes the significance of regulatory documentation, a key factor in the development, approval, and market entry of IVD devices.

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AboutThisCourse

With the global IVD market projected to reach $120.98 billion by 2027, the demand for experts proficient in regulatory documentation is surging. This course equips learners with essential skills to navigate the complex regulatory landscape, ensuring compliance and reducing time-to-market. By mastering the art of creating accurate, comprehensive, and compliant documentation, learners enhance their career growth opportunities. The course covers crucial topics such as regulatory strategies, documentation templates, and quality management systems, empowering professionals to make significant contributions to their organizations and the IVD industry.

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CourseDetails

• IVD Regulatory Landscape
• Understanding IVD Directive 98/79/EC
• ISO 13485:2016 Quality Management System for IVD Manufacturers
• Design Control and Risk Management in IVD Development
• Clinical Evidence and Performance Evaluation for IVDs
• Regulatory Submissions and Documentation for IVDs
• EU MDR and IVDR Implementation and Impact
• Post-Market Surveillance and Vigilance in IVDs
• Global Harmonization and International IVD Regulations

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EntryRequirements

  • BasicUnderstandingSubject
  • ProficiencyEnglish
  • ComputerInternetAccess
  • BasicComputerSkills
  • DedicationCompleteCourse

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  • NotAccreditedRecognized
  • NotRegulatedAuthorized
  • ComplementaryFormalQualifications

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FastTrack GBP £149
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AcceleratedLearningPath
  • ThreeFourHoursPerWeek
  • EarlyCertificateDelivery
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StandardMode GBP £99
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FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • DigitalCertificate
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EXECUTIVE DEVELOPMENT PROGRAMME IN IVD REGULATORY DOCUMENTATION
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UK School of Management (UKSM)
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05 May 2025
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