Global Certificate in ISO 13485 Implementation

Name: Global Certificate in ISO 13485 Implementation
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The Global Certificate in ISO 13485 Implementation is a comprehensive course that equips learners with the necessary skills to implement and maintain ISO 13485 quality management systems in medical device organizations. This course is critical for professionals seeking to advance their careers in the medical device industry, where ISO 13485 certification is a mandatory requirement.

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AboutThisCourse

This course covers essential topics, including the structure and requirements of ISO 13485, risk management, document control, and internal audits. By completing this course, learners will gain a deep understanding of the best practices in quality management and how to apply them in real-world scenarios. Moreover, learners will acquire the skills to ensure compliance with regulatory requirements, reducing the risk of non-compliance and ensuring the safety and efficacy of medical devices. In summary, the Global Certificate in ISO 13485 Implementation is a valuable course for professionals seeking to advance their careers in the medical device industry. This course provides learners with the necessary skills and knowledge to implement and maintain ISO 13485 quality management systems, ensuring compliance with regulatory requirements and promoting the safety and efficacy of medical devices.

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CourseDetails

• Introduction to ISO 13485
• Understanding Medical Device Quality Management Systems
• Benefits and Requirements of ISO 13485 Certification
• Key Principles of ISO 13485:2016
• Risk Management in ISO 13485
• Documentation Control for ISO 13485 Compliance
• Implementing ISO 13485: Planning, Implementation, and Verification
• Internal Audits and Management Review for ISO 13485
• Preparing for ISO 13485 Certification and the Certification Audit

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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
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StandardMode GBP £90

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FlexibleLearningPace

TwoThreeHoursPerWeek
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GLOBAL CERTIFICATE IN ISO 13485 IMPLEMENTATION

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London School of International Business (LSIB)

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05 May 2025

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