ISO 13485 Foundation

  • 4.8(45,222 Rating)

Course Overview

ISO 13485 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.

After completing this course, you can sit for the exam and apply for the “PECB Certificate Holder in ISO 13485 Foundation” certificate. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.

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

Educational approach

  • Lecture sessions are illustrated with practical questions and examples
  • Practical exercises include examples and discussions
  • Practice tests are similar to the Certificate Exam

Prerequisites

None

Target Audiance

  • 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

Schedule Dates

ISO 13485 Foundation
18 March 2024 - 19 March 2024
ISO 13485 Foundation
18 June 2024 - 19 June 2024
ISO 13485 Foundation
18 September 2024 - 19 September 2024
ISO 13485 Foundation
18 December 2024 - 19 December 2024

Course Content

  • Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485

  • Medical Devices Quality Management System requirements and Certificate Exam

FAQs

ISO 13485 Foundation refers to the basic level of understanding and knowledge about the ISO 13485 standard for Quality Management Systems (QMS) for Medical Devices. This certification or training equips individuals with the foundational principles, requirements, and terminology of ISO 13485, enabling them to contribute effectively to the development, implementation, and maintenance of quality management systems within organizations involved in the medical device industry.

ISO 13485 Foundation training is suitable for individuals across various roles within organizations that manufacture, distribute, or service medical devices, including but not limited to quality managers, regulatory affairs professionals, production managers, and personnel involved in quality assurance and regulatory compliance. It is also beneficial for those seeking to enhance their understanding of quality management specific to the medical device industry.

ISO 13485 Foundation training typically covers essential topics such as the purpose and scope of ISO 13485, the structure and requirements of the standard, key terminology, documentation requirements, the process approach to quality management, risk management, regulatory requirements, and the importance of product safety and effectiveness in the medical device industry. Participants also learn about the significance of customer focus, regulatory compliance, and continual improvement in maintaining quality management systems.

Obtaining ISO 13485 Foundation certification offers several benefits, including:

  • Enhanced understanding of quality management principles and practices specific to the medical device industry, as outlined in ISO 13485.
  • Improved ability to contribute to the development, implementation, and maintenance of quality management systems for medical devices within organizations.
  • Recognition as a qualified professional with knowledge of international standards and regulatory requirements relevant to medical device quality management.
  • Potential career advancement opportunities in roles related to quality management, regulatory affairs, and compliance within the medical device industry.
  • Contribution to the enhancement of product quality, safety, and regulatory compliance, leading to improved customer satisfaction and market competitiveness.
Start learning with 15.8k students around the world.
  • 3.3k
    Courses
  • 100+
    Certified Instructors
  • 99.9%
    Success Rate
Open chat
Hello
How Can We Help You?