Global Certificate in Healthcare Device Compliance Essentials Fundamentals

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The Global Certificate in Healthcare Device Compliance Essentials Fundamentals is a comprehensive course designed to meet the growing industry demand for professionals with expertise in healthcare device compliance. This course emphasizes the importance of understanding regulations and standards to ensure the safety and effectiveness of medical devices.

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AboutThisCourse

By enrolling in this course, learners will gain essential skills necessary for career advancement in the healthcare device industry. The course covers critical topics such as risk management, quality management systems, and regulatory affairs. Upon completion, learners will be equipped with the knowledge and skills to ensure compliance with regulatory requirements, reducing the risk of non-compliance and ensuring the safe and effective use of healthcare devices. In today's rapidly changing healthcare landscape, compliance with regulations is more critical than ever. This course provides learners with a solid foundation in compliance essentials, making them highly valuable to employers and advancing their careers in the healthcare device industry.

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CourseDetails

• Regulatory Frameworks: Understanding global regulations and guidelines for healthcare device compliance
• Risk Management: Implementing ISO 14971 and conducting risk assessment for medical devices
• Quality Management Systems: Establishing and maintaining QMS according to ISO 13485
• Design Control: Applying FDA design control requirements in product development
• Clinical Evaluation: Conducting clinical evaluations and preparing clinical evaluation reports
• Labeling and Packaging: Ensuring compliance with UDI, IFU, and other labeling requirements
• Post-Market Surveillance: Managing vigilance, PMS, and PSURs for continuous improvement
• Supply Chain Management: Ensuring compliance throughout the entire supply chain

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EntryRequirements

  • BasicUnderstandingSubject
  • ProficiencyEnglish
  • ComputerInternetAccess
  • BasicComputerSkills
  • DedicationCompleteCourse

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  • NotAccreditedRecognized
  • NotRegulatedAuthorized
  • ComplementaryFormalQualifications

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FastTrack GBP £149
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AcceleratedLearningPath
  • ThreeFourHoursPerWeek
  • EarlyCertificateDelivery
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StandardMode GBP £99
CompleteInTwoMonths
FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • DigitalCertificate
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GLOBAL CERTIFICATE IN HEALTHCARE DEVICE COMPLIANCE ESSENTIALS FUNDAMENTALS
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UK School of Management (UKSM)
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05 May 2025
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