ISO 13485 Foundation Course Overview

The ISO 13485 Foundation training course provides participants with the essential knowledge to implement and manage a Medical Devices Quality Management System (MDQMS) in accordance with ISO 13485 requirements. The training covers various modules of an MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review, and continual improvement.

Upon completing the course, participants have the option to take the exam and apply for the “PECB Certificate Holder in ISO 13485 Foundation” certificate. This certificate demonstrates their understanding of the fundamental methodologies, requirements, framework, and management approach related to ISO 13485 compliance.

Intended Audience

• Individuals involved in Medical Devices Quality Management
• Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
• Individuals interested to pursue a career in Medical Devices Quality Management

Learning Objectives

• Understand the elements and operations of a Medical Devices Quality Management System (MDQMS)
• Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
• Understand the approaches, methods and techniques used for the implementation and  management of a MDQMS

Benefits of taking ISO 13485 Foundation Training

Here are some of the benefits of taking ISO 13485 Foundation Training:

• Gain a comprehensive understanding of the ISO 13485 standard and its requirements: This training will provide you with a thorough understanding of the ISO 13485 standard, including its principles, requirements, and implementation guidelines. You will learn about the key concepts of quality management in the medical device industry and how to apply them to your organization’s processes and procedures.
• Enhance your skills in developing and implementing a medical device quality management system (QMS): This training will equip you with the practical skills and knowledge to develop and implement a QMS that meets the requirements of ISO 13485. You will learn how to identify and assess risks, design and implement controls, monitor and measure QMS effectiveness, and ensure continuous improvement.
• Prepare for ISO 13485 certification: This training will provide you with the foundation knowledge and skills to prepare for ISO 13485 certification audits. You will learn about the audit process, the types of questions to expect, and how to demonstrate compliance with the standard.
• Advance your career in the medical device industry: ISO 13485 certification is a valuable credential in the medical device industry. Completing ISO 13485 Foundation Training will demonstrate your commitment to quality and compliance and can open up new career opportunities.
• Stay up-to-date with the latest ISO 13485 requirements: ISO 13485 is a dynamic standard that is subject to periodic revisions. Taking ISO 13485 Foundation Training will help you stay up-to-date with the latest requirements and ensure that your organization’s QMS is always compliant.

In addition to these general benefits, ISO 13485 Foundation Training can also provide specific benefits for different types of professionals in the medical device industry:

• Medical device manufacturers: This training will help you to understand and comply with the regulatory requirements for medical device manufacturing. You will learn how to design and manufacture medical devices that meet the highest standards of quality and safety.
• Medical device distributors: This training will help you to understand the regulatory requirements for medical device distribution. You will learn how to distribute medical devices in a way that complies with the ISO 13485 standard and ensures patient safety.
• Medical device regulatory professionals: This training will provide you with a comprehensive understanding of the ISO 13485 standard and its application in the medical device industry. You will learn how to assess compliance with the standard and how to conduct ISO 13485 certification audits.

Overall, ISO 13485 Foundation Training is a valuable investment for anyone involved in the medical device industry. It can help you to gain the knowledge and skills you need to develop and implement a robust QMS, enhance your career prospects, and contribute to the safety and efficacy of medical devices.