Self Paced PECB ISO 13485 Lead Implementer

Buy this Self Paced training course (at your own pace) and receive the courses, quizzes, exercises and the code to take the exam within a period of 1 year

The option Self Paced gives you :

• Self-paced online course support in the KATE web or desktop application with exercises and quizzes and their answers
• The exam voucher with a retake : you will have one year to take the exam from the moment the voucher is generated
• PECB certification : you will receive your certification as soon as you have validated your exam and fulfilled the necessary conditions

ISO 13485 Lead Implementer

Why should you attend?

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.

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

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.