About the course

ISO 13485 Foundation training teaches you the fundamentals of implementing and managing an ISO 13485 Medical Devices Quality Management System (MDQMS). You will be able to understand the various modules of an MDQMS during this training course, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review, and continuous improvement.

Training done in collaboration with

 

Course Outlines

Duration

Up to six months

Learning Objectives

This training course enables you to:

  • 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

General Information

  • Certification and examination fees are included in the price of the training course.
  • PECB will provide training material of over 200 pages of information and practical examples.
  • An attendance record worth 14 CPD (Continuing Professional Development) credits will be issued to participants who have attended the training course.
  • In case of exam failure, the candidate can retake the exam once for free within 12 months of the initial exam date.

Course Details

Course Agenda

  • Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485.
  • Medical Devices Quality Management System requirements.
  • Certification Exam

Examination

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).

Frequently Asked Questions

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

What are the Prerequisites?

There are no prerequisites for taking this training course.

How does Self-paced training work?

This course is completed entirely online. You will be provided notes and training material and you can study at your own pace and in your own time.

You can begin whenever you choose and have up to 6 months to complete the course.

 

Categories:

ISO 13485 Foundation – Self-Study

448.40

Become acquainted with the best practices of Medical Devices Quality Management Systems (MDQMS) based on ISO 13485.

Course Price: €380 (Excl. Vat)

 

 

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