Introduction to Medical Devices Quality Management Systems (MDQMS) based on ISO 13485

ISO 13485 Foundation

Why should you attend?

ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.

 After completing this course, you can sit for the exam and apply for the “Certified ISO 13485 Foundation” credential. A Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach. 

Who should attend?

  • Individuals involved in Medical Devices Quality Management

  • Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)

  • Individuals interested to pursue a career in Medical Devices Quality Management

Learning objectives

  • Understand the elements and operations of a Medical Devices Quality Management System (MDQMS)

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks

  • Understand the approaches, methods and techniques used for the implementation and  management of a MDQMS

Educational approach

  • Lecture sessions are illustrated with examples based on case studies

  • Practical exercises are based on the material which includes role playing and discussions

  • Practice tests are similar to the Certification Exam

Prerequisites

 None

Course agenda

Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485

Day 2: Medical Devices Quality Management System requirements and Certification Exam

Examination

The “Certified ISO 13485 Foundation” exam fully meets the requirements of the Examination and Certification Programme (ECP). The exam covers the following competency domains:

Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Domain 2: Medical Devices Quality Management System (MDQMS)

Certification

Upon the successful completion of the exam, you can apply for the credential shown on the table below.

The requirements for Foundation Certification are:

Credential

Exam

Professional experience

MS audit/ assessment experience

MDMS project experience

Other requirements

Certified ISO 13485 Foundation

Certified ISO 13485 Foundation Exam or equivalent

None

None

None

Signing the Code of Ethics

General Information

  • Certification fees are included on the exam price
  • Training material containing over 200 pages of information and practical examples will be distributed
  • A participation certificate of 14 CPD (Continuing Professional Development) credits will be issued
  • In case of exam failure, you can retake the exam within 12 months for free