Online ISO 13485 Foundation Training #separator_sa Certified eLearning

Online ISO 13485 Foundation Training | CQI, IRCA & Exemplar Global Certified

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Online ISO 13485 Foundation Training (CQI & IRCA Certified) is ideal for anyone who wants to understand the underlying principles and requirements of the international standard, ISO 13485 (2016). This course has been designed for Quality Professionals.

Our 8hr eLearning course is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Subject Area
Medical Devices
8 Hours
USD $ 595.00  per person
Team Pricing
USD $ 2,380.00
CQI & IRCA (No. 2327), Exemplar Global

This ISO 13485 Foundation Training course is available via eLearning (24/7) offering you the most convenient & flexible way to learn online, anytime, anywhere. It is important to note that the exact time it takes to complete the eLearning modules will vary based on current knowledge, experience, and learning style.

Learning Objectives

On completion of this Online ISO 13485 Foundation Training, successful Learners will have the knowledge needed to:

  1. Explain the purpose of a medical device quality management system, of medical device quality management systems standards, and the business benefits of improved performance given by an effectively implemented medical device quality management system
  2. Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents
  3. Explain the specific quality management-related requirements of ISO 13485

Course Content

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Entry Requirements

It is recommended that each Learner should have the following prior knowledge before completing this course:

Management Systems

  • The Plan, Do, Check, Act (PDCA) cycle
  • The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.

Quality Management

  • The fundamental concepts and commonly used quality management terms and definitions

Fluency in written and spoken English

  • For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.

Copy of ISO 13485 (International Standard)

  • It is recommended that each Learner should have a copy of ISO 13485:2016 (International Standard) to reference while completing this course. This is not provided by Comply Guru and without it, this course will be challenging to complete successfully.

Assessment & Certification

Assessment Methodology

In order to successfully complete this course, each Learner will need to:

  • Complete the course modules and obtain 70% or higher in the final assessment (MCQ-based) within the 90-day course license


This course is certified by CQI & IRCA (No. 2327). Successful completion will entitle each Learner to receive a digital Certificate of Completion.