Certificate in ISO 13485 for Engineers

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The Certificate in ISO 13485 for Engineers is a comprehensive course that provides learners with the essential skills needed to design, implement, and maintain a quality management system in the medical device industry. This course highlights the importance of ISO 13485 in ensuring compliance with regulatory requirements and promoting continuous improvement in product quality and safety.

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AboutThisCourse

In today's rapidly evolving medical device industry, there is a high demand for professionals with a deep understanding of ISO 13485. This course equips learners with the knowledge and skills necessary to meet this demand, providing a clear pathway for career advancement. By earning this certificate, learners demonstrate their commitment to quality and regulatory compliance, setting themselves apart in a competitive job market. Through a combination of interactive lectures, real-world examples, and hands-on exercises, this course covers all aspects of ISO 13485, from risk management and document control to design and development, and more. By the end of the course, learners will have the skills and confidence needed to lead their organizations in achieving and maintaining ISO 13485 certification.

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CourseDetails

• Introduction to ISO 13485
• Benefits and Requirements of ISO 13485
• Understanding Quality Management Systems (QMS)
• Risk Management in Medical Devices
• Design and Development Controls in ISO 13485
• Documentation Controls and Record Keeping
• Production and Service Controls in ISO 13485
• Measurement, Analysis and Improvement
• Internal Audits and Management Review for ISO 13485
• Preparing for and Implementing ISO 13485 Certification

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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
  • OpenEnrollmentStartAnytime
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StandardMode GBP £90
CompleteInTwoMonths
FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • DigitalCertificate
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CERTIFICATE IN ISO 13485 FOR ENGINEERS
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London School of International Business (LSIB)
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05 May 2025
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