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ISO 13485 Foundation

ISO 13485 Medical Devices Quality Management System

Whether you have found the course you want, need a customized course, or are still unsure, complete the form to contact a member of the training team. Additionally, we can discuss team discounts and more.

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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

Course Agenda

Examination

Certificate Requirements

General Information

Related courses

Additional information

  • Training Days: 2
  • Qualifies for CPE: Yes
  • Exam Duration: 1 hour
  • Retake Exam: Yes

Course price

$500 Per Participant*

*Schellman assessment clients can enjoy professional training discounts.

PECB Logo

Training content and exams are delivered through PECB:
https://pecb.com/en/education-and-certification-for-individuals/iso-13485/iso-13485-foundation

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