Executive Development Programme in ISO 13485 Transformation

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The Executive Development Programme in ISO 13485 Transformation is a certificate course designed to equip learners with the necessary skills to implement and manage ISO 13485 quality management systems in medical device organizations. This course is essential for professionals seeking to advance their careers in the medical device industry, where compliance with ISO 13485 is a critical requirement.

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AboutThisCourse

The demand for this course is high, as the global medical device market is projected to reach $612.7 billion by 2025, according to Grand View Research. With this growth comes an increased need for professionals who can ensure compliance with quality management standards. This course covers the latest best practices and trends in ISO 13485, providing learners with practical skills and knowledge to drive transformation in their organizations. By completing this course, learners will be able to demonstrate their expertise in implementing and managing ISO 13485 quality management systems, making them highly valuable to employers in the medical device industry.

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CourseDetails

• Introduction to ISO 13485 & Medical Device Quality Management System
• Benefits & Challenges of ISO 13485 Transformation
• Regulatory Framework & Compliance in ISO 13485
• Gap Analysis & Implementation Planning for ISO 13485
• Key Elements of ISO 13485: Management Responsibility, Resource Management, Product Realization, Measurement, Analysis and Improvement
• Risk Management in ISO 13485 Transformation
• Documentation Control & Record Keeping in ISO 13485
• Internal Audit & Management Review for ISO 13485
• Preparing for & Executing ISO 13485 Certification Audit
• Continuous Improvement in ISO 13485 & Maintaining Certification

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EntryRequirements

  • BasicUnderstandingSubject
  • ProficiencyEnglish
  • ComputerInternetAccess
  • BasicComputerSkills
  • DedicationCompleteCourse

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  • NotRegulatedAuthorized
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FastTrack GBP £140
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AcceleratedLearningPath
  • ThreeFourHoursPerWeek
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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 ISO 13485 TRANSFORMATION
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London School of International Business (LSIB)
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05 May 2025
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