Undergraduate Certificate in Quality Assurance of Medical Devices

Name: Undergraduate Certificate in Quality Assurance of Medical Devices
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The Undergraduate Certificate in Quality Assurance of Medical Devices is a comprehensive course that equips learners with critical skills necessary for ensuring the highest standards in medical device production. This program emphasizes the importance of quality assurance and regulatory compliance, making it highly relevant in an industry where precision and safety are paramount.

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AboutThisCourse

In this course, students will gain a solid understanding of quality assurance principles, regulatory requirements, and risk management strategies specific to medical devices. They will learn how to implement and manage quality systems, perform essential tests, and analyze data to ensure product safety and efficacy. With the growing demand for medical devices and the increasing focus on patient safety, this course offers learners an excellent opportunity to advance their careers in this high-growth industry. By completing this program, learners will be well-prepared to take on roles such as Quality Assurance Specialist, Regulatory Affairs Coordinator, or Compliance Officer, contributing to the development of life-saving medical technologies.

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CourseDetails

• Introduction to Quality Assurance in Medical Devices: Fundamentals of quality assurance, regulations, and standards in medical devices
• Medical Device Design Control: Design and development process, design inputs, outputs, and verification
• Risk Management in Medical Devices: ISO 14971, risk identification, assessment, and control
• Quality Systems for Medical Devices: ISO 13485, quality management system requirements
• Medical Device Production and Process Control: Production processes, control methods, and documentation
• Medical Device Inspection and Testing: Inspection and testing methods, acceptance criteria, and statistical techniques
• Medical Device Product Verification and Validation: Validation principles, protocols, and reporting
• Complaint Handling and Medical Device Vigilance: Adverse event reporting, complaint handling, and vigilance systems
• Medical Device Quality Assurance Case Studies: Real-world examples and best practices

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EntryRequirements

BasicUnderstandingSubject
ProficiencyEnglish
ComputerInternetAccess
BasicComputerSkills
DedicationCompleteCourse

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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
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UNDERGRADUATE CERTIFICATE IN QUALITY ASSURANCE OF MEDICAL DEVICES

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London School of International Business (LSIB)

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05 May 2025

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