ISO 13485

Lead Implementer

PECB Certified

ISO 13485 Lead Implementer

Name: ISO 13485 Lead Implementer
Price: 945 EUR

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

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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

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

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

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

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

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

Format and price

eLearning€1,195

All taxes included · Includes PECB exam voucher

Participant

Discounts and regional pricing are available. See which discounts apply

Withdrawal

I ask Standards Academy to give me access to the course immediately. I understand and accept that once access has been given I lose my right to cancel within fourteen days and I will not be entitled to a refund. Where the course is treated as a service, I ask for it to begin immediately and I accept that my right to cancel ends once it has been fully delivered.

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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