Name: ISO 13485 Lead Implementer
SKU: 4600
Availability: InStock

ISO 13485 Lead Implementer

Description

The PECB ISO 13485 Lead Implementer Certification course empowers participants to master the implementation and management of a Medical Devices Quality Management System (MDQMS) based on ISO 13485. This comprehensive training covers essential concepts, approaches, methods, and techniques for effective MDQMS implementation. Designed for managers, consultants, and professionals responsible for MDQMS conformance, the course aims to enhance organizational performance by ensuring the consistent delivery of safe and high-quality medical devices. By completing this course, participants gain the expertise to lead MDQMS projects, preparing them for the certification exam and advancing their professional capabilities.

Why Should You Attend the ISO 13485 Lead Implementer 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.

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

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

Educational Approach

This training is based on both theory and best practices used in the implementation of a MDQMS
Lecture sessions are illustrated with examples based on case studies
Practical exercises are based on a case study which includes role playing and discussions
Practice tests are similar to the Certification Exam

Prerequisites

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