---
title: "ISO 13485 Foundation | Standards Academy"
url: https://standards.academy/courses/iso-13485-foundation
description: "Learn the elements of a medical device quality management system as specified in ISO 13485 in this two-day PECB certification course. The course covers the…"
lang: en
---

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ISO 13485

Foundation

PECB Certified

# ISO 13485 Foundation

Learn the elements of a medical device quality management system as specified in ISO 13485 in this two-day PECB certification course. The course covers the quality policy, procedures, performance measurement, internal audit and continual improvement. Earn the internationally recognized PECB Certificate Holder in ISO 13485 Foundation credential.

2 Days

14 CPD Credits

Exam Included

Back to All Courses (https://standards.academy/courses)

## About This Course

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

## Learning Objectives

1

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

2

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

3

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 Certificate Exam

## 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

## Prerequisites

No specific prerequisites required. Familiarity with management system concepts is helpful but not required.

## Frequently asked questions

### Do you offer discounts?

### Why is my price different from the list price?

1

Format and price

eLearning €645

All taxes included · Includes PECB exam voucher

2

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Discounts and regional pricing are available. See which discounts apply (https://standards.academy/discounts)

3

Withdrawal

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### Quick Facts

Duration

2 days

CPD Credits

14

Language

English

Provider

PECB

Category

Quality & Management

### What's Included

- 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.

### Downloads

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