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ISO 13485 Foundation

ISO 13485 Foundation ISO 13485 Lead Implementer ISO 13485 Lead Auditor

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 “PECB Certificate Holder in ISO 13485 Foundation” certificate. A PECB 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 practical questions and examples
  • Practical exercises include examples and discussions
  • Practice tests are similar to the Certificate Exam

Prerequisites

None.

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 Certificate Exam

The exam fully meets the requirements of the PECB Examination and Certificate Programme. It 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)

For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.

After successfully completing the exam, you can apply for the credential shown on the table below.

The certificate requirements for the ISO 13485 Foundation are:

Designation Training Course Exam Professional experience MS audit/assessment experience BCMS project experience Other requirements
PECB Certificate Holder in ISO 13485 Foundation PECB ISO 13485 Foundation Pass the PECB ISO 13485 Foundation Exam None None None Signing the PECB Code of Ethics
  • Certificate and examination fees are included in the price of the training course
  • Training material containing over 200 pages of information and practical examples will be distributed
  • An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, you can retake the exam within 12 months for free

For additional information, please contact us at support@pecb.com.

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