Certificate in ISO 13485: Core Principles

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The Certificate in ISO 13485: Core Principles is a comprehensive course designed to equip learners with the essential skills needed to excel in the medical device industry. This course focuses on the importance of ISO 13485, an international standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry.

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AboutThisCourse

By completing this course, learners will gain a deep understanding of the core principles of ISO 13485 and how to implement them in real-world scenarios. The demand for professionals with expertise in ISO 13485 is high, making this course an excellent opportunity for career advancement. With a certificate in ISO 13485: Core Principles, learners will have the skills and knowledge needed to succeed in this critical and growing field.

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CourseDetails

• Introduction to ISO 13485
• Benefits and Importance of ISO 13485
• Understanding Quality Management Systems (QMS)
• Key Principles and Requirements of ISO 13485
• Risk Management in ISO 13485
• Documentation Control in ISO 13485
• Implementing ISO 13485 in Medical Device Manufacturing
• Internal Audits and Management Review for ISO 13485
• Preparing for ISO 13485 Certification Audit
• Maintaining and Continual Improvement of ISO 13485

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EntryRequirements

  • BasicUnderstandingSubject
  • ProficiencyEnglish
  • ComputerInternetAccess
  • BasicComputerSkills
  • DedicationCompleteCourse

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  • NotAccreditedRecognized
  • NotRegulatedAuthorized
  • ComplementaryFormalQualifications

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FastTrack GBP £140
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AcceleratedLearningPath
  • ThreeFourHoursPerWeek
  • EarlyCertificateDelivery
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StandardMode GBP £90
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FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • DigitalCertificate
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CERTIFICATE IN ISO 13485: CORE PRINCIPLES
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London School of International Business (LSIB)
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05 May 2025
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