Courses Overview

This ISO 13485 Medical Devices Quality Management training is given to corporate and individual who are aiming for an international certificate. Which will be provided upon completing the training and passing the  examination certification from PECB Canada. Corporate trainings is deliver in accordance to companies respective industry requirement. Following the quality and international standard.

ISO 13485 Introduction

ISO 13485 Medical Devices Quality Management – Introduction training course enables you to comprehend the basic concepts of Medical Devices Quality Management System (MDQMS). By attending the ISO 13485 Introduction course, you will understand the importance of a Medical Devices Quality Management System (MDQMS) and the benefits that businesses, society and governments can obtain.

ISO 13485 Foundation

ISO 13485 Medical Devices Quality Management –  Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.

ISO 13485 Lead Implementer

ISO 13485 Medical Devices Quality Management – 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.

ISO 13485 Lead Auditor

ISO 13485 Medical Devices Quality Management – Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures and techniques. During this training course, you will acquire the necessary knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and the certification process according to ISO/IEC 17021-1.