ISO 13485: Medical Devices Quality Management System Lead Implementer

ISO 13485 Lead Implementer (PECB)

Medical Devices Quality Management System

Brief Course Description

This Medical Devices Quality Management System (MDQMS) Lead Implementer training course is presented by a certified PECB instructor either in a live classroom setup, or over an online meeting format. The course duration is five days. The certification exam will be held on day five of the course. Once you pass the exam, you can apply for the credential appropriate to your personal career level of experience.

You will receive 31 Continuing Professional Development (CPD) credits, and will receive course materials for your continued study.

You can take this course using PECB's eLearning format.

Why should I take this course?

When completed, you will be able to plan, lead, and implement a Medical Devices Quality Management System (MDQMS) based on ISO 13485 for any entity needing it.

How does this work?

FSE|ICC is a certified PECB reseller. We handle the transaction with you and then we will provide you access to course content, instruction, examinations, and anything else associated with the course.

How do I get started?

Add this course to your cart by tapping/clicking the "Add to Cart" button above, and finish the checkout process. We will contact you directly and help you register for the course that best fits your schedule. If you have questions, drop us an email at info@fseicc.com. We'll answer your questions.

ISO 13485 Lead Implementer

How will you benefit from this course?

This training course will enable 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. 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.

Once you complete the course, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. Holding a Lead Implementer Certificate demonstrates that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.

Are you one of these?

  • Manager or consultant involved in Medical Devices Quality Management
  • Expert advisor seeking to master the implementation of a Medical Devices Quality Management System
  • Individual responsible for maintaining conformance with MDQMS requirements
  • MDQMS team member

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

Prerequisites

A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.

ISO 13485 Lead Implementer

The Five-day 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

ISO 13485 Lead Implementer 

Examination

The exam covers the following competence domains:

Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Domain 2: Medical Devices Quality Management System (MDQMS)

Domain 3: Planning a MDQMS implementation based on ISO 13485

Domain 4: Implementing a MDQMS based on ISO 13485

Domain 5: Performance evaluation, monitoring and measurement of a MDQMS based on ISO 13485

Domain 6: Continual improvement of a MDQMS based on ISO 13485

Domain 7: Preparing for a MDQMS certification audit

For more detailed information about the PECB exam process, please visit Examination Rules and Policies.

ISO 13485 Lead Implementer

Certification

22000 Lead Implementer certification for the win

Once you pass the exam, you will be able apply for a credential appropriate to your experience. You will receive the certificate after you show that you comply with all the requirements related to the credential.

For more information about ISO 13485 certifications and the PECB certification process, please refer to the Certification Rules and Policies.

ISO 13485 Lead Implementer

General Information

  • The course fee includes the cost of the exam and certification.
  • You will receive over 450 pages of training material containing explanatory information and practical examples.
  • You will be issued 31 CPD (continuing professional development) credits once you complete the course.
  • If you fail the exam, you will be able to retake the exam once for free within 12 months following the initial exam date.

Quick Link:

ISO 13485 Lead Implementer Course Brochure

Learn to implement a Medical Devices Quality Management System

$1,091.00

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