Executive Development Programme in Medical Device Regulatory Affairs for the Future

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The Executive Development Programme in Medical Device Regulatory Affairs for the Future is a certificate course designed to empower professionals with the necessary skills to navigate the complex regulatory landscape of the medical device industry. This programme emphasizes the importance of regulatory compliance and its critical role in bringing innovative medical devices to market, ensuring patient safety, and driving business success.

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AboutThisCourse

In an era of rapid technological advancement and increasing regulatory scrutiny, there is a high industry demand for experts who can effectively manage regulatory affairs. This course equips learners with essential skills, knowledge, and tools to excel in this field, providing a comprehensive understanding of global regulatory requirements, quality management systems, clinical trials, and product lifecycle management. By completing this programme, professionals can accelerate their career growth, gain a competitive edge, and contribute to their organization's success in bringing life-changing medical devices to market.

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CourseDetails

• Fundamentals of Medical Device Regulatory Affairs
• Global Regulatory Landscape for Medical Devices
• Quality Management Systems and ISO 13485
• European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
• US Medical Device Regulations (FDA) and Pre-market Approval (PMA) process
• Regulatory Strategies for Medical Device Innovation
• Clinical Evaluation and Post-Market Surveillance
• Medical Device Cybersecurity and Data Privacy
• Global Harmonization and Mutual Recognition Agreements
• Future Trends in Medical Device Regulatory Affairs

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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
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AcceleratedLearningPath
  • ThreeFourHoursPerWeek
  • EarlyCertificateDelivery
  • OpenEnrollmentStartAnytime
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StandardMode GBP £90
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FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • DigitalCertificate
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EXECUTIVE DEVELOPMENT PROGRAMME IN MEDICAL DEVICE REGULATORY AFFAIRS FOR THE FUTURE
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London School of International Business (LSIB)
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05 May 2025
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