---
title: "ISO 13485 Lead Implementer | Standards Academy"
url: https://standards.academy/courses/iso-13485-lead-implementer
description: "Master the implementation and management of a medical device quality management system based on ISO 13485 in this five-day PECB certification course. The…"
lang: en
---

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ISO 13485

Lead Implementer

PECB Certified

# ISO 13485 Lead Implementer

Master the implementation and management of a medical device quality management system based on ISO 13485 in this five-day PECB certification course. The course covers establishing, maintaining and continually improving the system in a regulated environment. Earn the internationally recognized PECB Certified ISO 13485 Lead Implementer credential.

5 Days

31 CPD Credits

Exam Included

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

## About This Course

ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization's overall performance by consistently providing safe and qualitative medical devices.

After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.

## Learning Objectives

1

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

2

Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS

3

Learn how to interpret the ISO 13485 requirements in the specific context of an organization

4

Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS

5

Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices

## Course Agenda

Day 1

Introduction to ISO 13485 and initiation of a MDQMS

Day 2

Plan the implementation of a MDQMS

Day 3

Implementation of a MDQMS

Day 4

MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit

Day 5

Certification Exam

## Who Should Attend

Managers or consultants involved in Medical Devices Quality Management

Expert advisors seeking to master the implementation of a Medical Devices Quality Management System

Individuals responsible for maintaining conformance with MDQMS requirements

MDQMS team members

## 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 €1,195

All taxes included · Includes PECB exam voucher

2

Participant

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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

5 days

CPD Credits

31

Language

English

Provider

PECB

Category

Quality & Management

### What's Included

- Certification and examination fees are included in the price of the training course
- Training material containing over 450 pages of information and practical examples will be distributed
- An attestation of course completion worth 31 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

Course Brochure: https://uqodmmmqsdvwwdqqtwqs.supabase.co/storage/v1/object/public/course-brochures/iso-13485-lead-implementer-4p.pdf

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