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ISO 13485 Lead Implementer

60 hours
All levels
5 lessons
0 quizzes
0 students

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.

Understanding of Python programming language 

Program and games creation using Python 2 & 3 

Knowledge of GUI creation 

Advanced Python features such as collections module & timestamps 

Students and freshers with interest in coding 

IT professionals looking for a domain with utmost job security 

Non- IT professionals willing to enter into IT with easy coding  


Organizations focusing on leveraging Python on a large scale 

Information

General Information

Understanding of Python programming language 

Program and games creation using Python 2 & 3 

Knowledge of GUI creation 

Advanced Python features such as collections module & timestamps 

Students and freshers with interest in coding 

IT professionals looking for a domain with utmost job security 

Non- IT professionals willing to enter into IT with easy coding  


Organizations focusing on leveraging Python on a large scale 

Certification fees are included on the exam price

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.

Attend

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

Objectives

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

Education

Examination

The “PECB Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency 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

Course

Certificate

After successfully completing the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential. For more information about ISO 13485 certifications and the PECB certification process, please refer to the Certification Rules and Policies.

Course

Prerequisites

 None

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