ISO 13485 Foundation Course Overview

To successfully undertake training in the ISO 13485 Foundation course, it is beneficial for participants to have the following minimum prerequisites:

• A basic understanding of quality management principles and concepts.
• Familiarity with general business processes and their interrelation within an organization.
• Awareness of the core purpose of a Medical Devices Quality Management System (MDQMS) and its importance in the medical devices industry.
• An interest in or some exposure to regulatory requirements relevant to the production or distribution of medical devices.
• No specific prior knowledge of the ISO 13485 standard is required, but any previous experience with ISO standards or quality systems in a healthcare or medical device context can be advantageous.

These prerequisites ensure that participants can effectively engage with the course material and contribute to discussions. However, the course is designed to provide foundational knowledge, so a willingness to learn and engage with the content is the most critical requirement.

Target Audience for ISO 13485 Foundation

The ISO 13485 Foundation course imparts crucial knowledge on MDQMS for professionals in the medical device sector.

• Quality Assurance Managers and Engineers
• Regulatory Affairs Specialists
• R&D Engineers
• Production Managers
• Supply Chain and Operations Managers
• Medical Device Consultants
• Clinical Affairs Professionals
• Internal and External Auditors
• Compliance Officers
• Individuals seeking to enter the medical device field
• Project Managers in the Medical Device Industry
• Manufacturing Engineers
• Product Designers and Developers within the Medical Device Field

Learning Objectives - What you will Learn in this ISO 13485 Foundation?

Introduction to Learning Outcomes

Gain foundational insights into the ISO 13485:2016 standard, comprehend its significance for quality management in the medical device industry, and learn the key requirements for certification.

Learning Objectives and Outcomes

• Understand the structure and key objectives of the ISO 13485:2016 standard.
• Recognize the importance of ISO 13485 and its impact on an organization’s quality management system.
• Identify the general requirements for establishing a Medical Devices Quality Management System (MDQMS).
• Learn about the documentation requirements necessary to meet ISO 13485 standards.
• Explore the roles and responsibilities of management within a MDQMS.
• Understand the resource requirements and how to effectively manage them.
• Grasp the processes of product realization and its critical aspects within MDQMS.
• Comprehend infrastructure requirements as they relate to the quality management of medical devices.
• Develop a foundational understanding of risk management principles in the context of ISO 13485.
• Prepare for the ISO 13485 Foundation certification exam, focusing on key concepts and knowledge areas essential for compliance.