Professional Certificate in Medical Device Regulatory Pathways

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The Professional Certificate in Medical Device Regulatory Pathways is a comprehensive course designed to provide learners with a deep understanding of the regulatory frameworks governing medical devices. This course is crucial in an industry where regulatory compliance is paramount.

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AboutThisCourse

With the increasing demand for medical devices, there is a high industry need for professionals who are well-versed in regulatory pathways. This course equips learners with the essential skills to navigate the complex regulatory landscape, ensuring the safe and timely market entry of medical devices. Through this course, learners gain expertise in global regulatory strategies, clinical trial design, and post-market surveillance. They also learn how to interpret and apply regulations from authorities like the FDA and EU MDR. By the end of this course, learners are equipped with the skills necessary for career advancement in regulatory affairs, clinical affairs, or quality assurance in the medical device industry.

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CourseDetails

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• Medical Device Regulations Overview
• Types of Medical Devices
• Global Medical Device Regulatory Bodies
• US FDA Regulatory Pathways
• European Union Medical Device Regulation (MDR) & In Vitro Diagnostic Regulation (IVDR)
• Canadian Medical Device Regulations (CMDR)
• Asian Medical Device Regulatory Landscape
• Post-Market Surveillance & Vigilance
• Quality Management System (QMS) for Medical Devices

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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 £140
CompleteInOneMonth
AcceleratedLearningPath
  • ThreeFourHoursPerWeek
  • EarlyCertificateDelivery
  • OpenEnrollmentStartAnytime
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StandardMode GBP £90
CompleteInTwoMonths
FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • FullCourseAccess
  • DigitalCertificate
  • CourseMaterials
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PROFESSIONAL CERTIFICATE IN MEDICAL DEVICE REGULATORY PATHWAYS
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London School of International Business (LSIB)
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05 May 2025
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