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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About this course

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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Course Details

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

Career Path

Entry Requirements

  • Basic understanding of the subject matter
  • Proficiency in English language
  • Computer and internet access
  • Basic computer skills
  • Dedication to complete the course

No prior formal qualifications required. Course designed for accessibility.

Course Status

This course provides practical knowledge and skills for professional development. It is:

  • Not accredited by a recognized body
  • Not regulated by an authorized institution
  • Complementary to formal qualifications

You'll receive a certificate of completion upon successfully finishing the course.

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UNDERGRADUATE CERTIFICATE IN QUALITY ASSURANCE OF MEDICAL DEVICES
is awarded to
Learner Name
who has completed a programme at
London School of International Business (LSIB)
Awarded on
05 May 2025
Blockchain Id: s-1-a-2-m-3-p-4-l-5-e
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