Certificate in Device Oversight Regulatory Affairs Fundamentals

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The Certificate in Device Oversight Regulatory Affairs Fundamentals is a comprehensive course designed to meet the growing industry demand for professionals with a solid understanding of medical device regulatory affairs. This program emphasizes the importance of regulatory compliance in the development, approval, and post-market surveillance of medical devices.

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AboutThisCourse

By enrolling in this course, learners will gain essential skills in regulatory strategies, quality systems, and compliance requirements. They will be equipped to navigate the complex regulatory landscape, ensuring the safety and efficacy of medical devices while minimizing compliance risks. This certificate course is an excellent opportunity for professionals seeking career advancement in regulatory affairs, quality assurance, or compliance management in the medical device industry. Upon completion, learners will have a strong foundation in regulatory affairs, enabling them to contribute to their organization's success and stay competitive in the evolving medical device market.

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CourseDetails

• Regulatory Affairs Overview
• Medical Device Classification and Regulation
• Global Regulatory Landscape for Medical Devices
• Device Lifecycle Management and Regulatory Compliance
• Understanding FDA Regulations and Guidelines
• European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
• Clinical Trials and Data Requirements for Device Submissions
• Post-Market Surveillance and Vigilance
• Quality Management Systems and ISO 13485
• Risk Management and Safety for Medical Devices

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*Source: Glassdoor, December 2021

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
  • OpenEnrollmentStartAnytime
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StandardMode GBP £99
CompleteInTwoMonths
FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • DigitalCertificate
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CERTIFICATE IN DEVICE OVERSIGHT REGULATORY AFFAIRS FUNDAMENTALS
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UK School of Management (UKSM)
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05 May 2025
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