Global Certificate in ISO 13485: Driving Business Value

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The Global Certificate in ISO 13485 is a distinguished course that equips learners with the essential skills needed to excel in the medical device industry. This certificate program emphasizes the importance of implementing a quality management system that complies with ISO 13485 standards, thereby driving business value and ensuring regulatory compliance.

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About this course

In an industry where quality and safety are paramount, this course is in high demand. Learners will gain a comprehensive understanding of the requirements for medical device quality management systems and develop the skills necessary to lead and manage a quality management system implementation project. Upon completion, learners will be able to demonstrate their expertise in ISO 13485 and their commitment to quality and compliance. This will enhance their career prospects and enable them to contribute to their organization's success in the medical device industry.

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Course Details


• Introduction to ISO 13485
• Benefits and Objectives of ISO 13485
• Scope and Application of ISO 13485
• Understanding Medical Device Quality Management System
• Key Principles and Requirements of ISO 13485
• Implementing ISO 13485 in Your Organization
• Risk Management in ISO 13485
• Documentation and Record Keeping in ISO 13485
• Internal Audit and Management Review for ISO 13485
• Continuous Improvement and Achieving Business Value with ISO 13485

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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Sample Certificate Background
GLOBAL CERTIFICATE IN ISO 13485: DRIVING BUSINESS VALUE
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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