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ISO 13485 Quality Management Foundation

ISO 13485 determines the requirements for the medical devices industry. This standard was established to be used by companies during the life cycle of medical devices, from the production to post-production, including decommission and disposal.

Description

 

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 Certified ISO 13485 Foundation” credential. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach. 

About This Course

 

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

 

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  

 

Assessment

 

The “PECB Certified ISO 13485 Foundation” exam fully meets the requirements of the PECB 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)

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

 

Prerequisites

 

None

What's Included?

 

  • Certification fees are included on the exam price
  • 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

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

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