Certificate in EU Medical Device Certification

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The Certificate in EU Medical Device Certification course is a comprehensive program designed to equip learners with the necessary skills to excel in the medical device industry. This course is crucial in the current industry landscape, where the demand for professionals with a deep understanding of EU medical device regulations is at an all-time high.

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AboutThisCourse

The course covers essential topics such as MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Device Regulation), providing learners with a solid foundation in EU medical device certification. By completing this course, learners will be able to demonstrate their expertise in navigating the complex regulatory landscape of the EU medical device market. This certification will open up exciting career advancement opportunities for learners, as they will be equipped with the skills and knowledge necessary to help medical device companies achieve regulatory compliance. By staying up-to-date with the latest EU medical device regulations, learners will be well-positioned to make valuable contributions to their organizations and the medical device industry as a whole.

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Here are the essential units for a Certificate in EU Medical Device Certification:


• EU Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR)
• Understanding the Conformity Assessment Process
• Quality Management Systems for Medical Devices
• Clinical Evaluation and Technical Documentation
• EU Medical Device Vigilance and Post-Market Surveillance
• Understanding Notified Bodies and their Role in EU MDR/IVDR
• EU Medical Device Classification and Risk Management
• EU Medical Device Labeling and UDI Requirements
• Preparing for and Passing the EU MDR/IVDR Certification Audit
• Changes and Challenges in EU Medical Device Certification under MDR/IVDR

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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 EU MEDICAL DEVICE CERTIFICATION
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UK School of Management (UKSM)
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05 May 2025
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