Professional Certificate in ISO 13485 for Healthcare

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The Professional Certificate in ISO 13485 for Healthcare is a comprehensive course designed to equip learners with the necessary skills to implement and maintain a quality management system in the medical device industry. This certification is essential for professionals seeking to advance their careers in healthcare, as it demonstrates a deep understanding of ISO 13485, a crucial standard for the design, production, installation, and servicing of medical devices.

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AboutThisCourse

With the increasing demand for quality management in the healthcare sector, this course is highly relevant and valued by employers. It covers critical topics such as risk management, document control, and continuous improvement, providing learners with a strong foundation in quality management principles. By completing this course, learners will be able to demonstrate their expertise in ISO 13485 and their commitment to quality, making them highly attractive candidates for career advancement opportunities in the healthcare industry. In summary, this course is crucial for professionals seeking to enhance their skills, knowledge, and career prospects in the rapidly evolving healthcare sector.

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Here are the essential units for a Professional Certificate in ISO 13485 for Healthcare:

  • • ISO 13485:2016 Overview
  • • Quality Management System (QMS) Requirements
  • • Medical Device Life Cycle and Risk Management
  • • Documentation and Record Keeping
  • • Management Review and Internal Audits
  • • Corrective and Preventive Action (CAPA) Process
  • • Training and Competence Requirements
  • • Validation, Verification, and Monitoring
  • • Supplier Management and Control
  • • Continuous Improvement in Healthcare Quality

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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
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • DigitalCertificate
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PROFESSIONAL CERTIFICATE IN ISO 13485 FOR HEALTHCARE
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London School of International Business (LSIB)
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05 May 2025
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