Certificate in ISO 13485 Documentation

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The Certificate in ISO 13485 Documentation course is a professional development program that focuses on the creation and management of quality management systems in the medical device industry. This course is essential for those looking to advance their careers in this field, as it provides learners with the necessary skills to ensure compliance with regulatory requirements and industry best practices.

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AboutThisCourse

ISO 13485 is an internationally recognized standard for medical device quality management systems, and demonstrating expertise in this area can be a significant advantage in the job market. The course covers topics such as document control, risk management, and internal auditing, and provides learners with hands-on experience in creating and maintaining ISO 13485-compliant documentation. As the medical device industry continues to grow and evolve, the demand for professionals with expertise in ISO 13485 documentation is expected to increase. By completing this course, learners will be well-positioned to take on leadership roles in quality management and contribute to the success of their organizations in this highly regulated industry.

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CourseDetails

• Introduction to ISO 13485
• Understanding ISO 13485 Documentation Requirements
• Developing a Quality Manual for ISO 13485
• Creating Procedures and Work Instructions
• Design and Development Controls for Medical Devices
• Document Control and Record Management
• Internal Audit and Management Review
• Corrective and Preventive Action Process
• Training and Competence for 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 DOCUMENTATION
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London School of International Business (LSIB)
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05 May 2025
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