Certificate in Medical Device Quality Assurance Standards

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The Certificate in Medical Device Quality Assurance Standards course is a vital program for professionals seeking expertise in the medical device industry. This course emphasizes the importance of quality assurance, compliance with regulations, and risk management in medical device production.

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AboutThisCourse

Learners will gain critical skills in implementing quality systems, conducting internal audits, and addressing corrective and preventive actions. With the global medical device market projected to reach $612.7 billion by 2025, the demand for professionals trained in quality assurance is rising. This course equips learners with the essential skills and knowledge to advance their careers, meet industry needs, and contribute to safer medical devices for patients. Upon completion, learners will be prepared to sit for the ASQ Certified Biomedical Auditor (CBA) or Certified Quality Auditor (CQA) exams, further enhancing their career prospects in the medical device industry.

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Here are the essential units for a Certificate in Medical Device Quality Assurance Standards:

• Introduction to Medical Device Quality Assurance Standards
• Understanding ISO 13485:2016 - Medical devices – Quality management systems – Requirements for regulatory purposes
• Risk Management in Medical Devices: An Introduction to ISO 14971
• Quality Assurance in Medical Device Design and Development
• Good Manufacturing Practices (GMP) for Medical Devices
• Medical Device Validation and Qualification
• Quality Assurance for Sterile Medical Devices
• Monitoring and Measuring Medical Device Quality
• Complaint Handling and Corrective and Preventive Action (CAPA) in Medical Devices

These units provide a comprehensive overview of the essential quality assurance standards and practices for medical devices, including regulatory requirements, risk management, design and development, manufacturing practices, validation, sterilization, and continuous improvement.

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  • BasicUnderstandingSubject
  • ProficiencyEnglish
  • ComputerInternetAccess
  • BasicComputerSkills
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FastTrack GBP £149
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  • ThreeFourHoursPerWeek
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StandardMode GBP £99
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FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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CERTIFICATE IN MEDICAL DEVICE QUALITY ASSURANCE STANDARDS
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UK School of Management (UKSM)
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05 May 2025
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