Description
This package includes official registration for the PECB ISO 13485 Foundation exam, along with comprehensive training materials. It is designed for professionals who want to understand the fundamental principles and processes of a Medical Devices Quality Management System (MDQMS) based on ISO 13485.
Ideal for those beginning their journey in medical device quality management, or for professionals seeking to build a clear understanding of MDQMS before advancing to higher-level certifications.
What’s Included:
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Official PECB ISO 13485 Foundation exam registration
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Training course materials with explanations, examples, and exercises
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Digital resources and practice questions to support exam preparation
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1-year exam validity
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Free second exam attempt if needed
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Online exam format – take it from anywhere, anytime via PECB Exams
Why Choose This Package?
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Learn the basic concepts and operations of a Medical Devices Quality Management System
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Gain understanding of MDQMS policies, procedures, audits, reviews, and continual improvement processes
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See how ISO 13485 aligns with other standards and regulatory frameworks
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Acquire the methodologies, requirements, and management approaches for MDQMS implementation
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Prepare effectively for certification with interactive exercises and practice tests
Who Is This For?
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Individuals working in or entering the field of medical device quality management
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Professionals seeking foundational knowledge of MDQMS processes and requirements
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Students and early-career professionals interested in pursuing a career in medical devices and compliance
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Anyone aiming to earn a globally recognized ISO 13485 Foundation certification








