ISO 13485 Foundation

ISO (International Organization for Standardization) is an independent, non-governmental, international organization that develops standards to improve the quality, safety, and efficiency of products or services.

ISO 13485 is an international standard that outlines the quality standards for organizations that design, develop, and manufacture medical devices.

ISO 13485 Medical Devices Quality Management System allows organizations to demonstrate their ability to provide medical devices and related services that consistently meet their customers’ and regulatory requirements.

Our ISO 13485 Foundation course also includes the exam to allow learners to test and establish their knowledge of the ISO 13485 standard learned during this course.

• 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 an MDQMS

• Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485
• Day 2: Medical Devices Quality Management System requirements and Certification Exam

By becoming an ISO 13485 certified professional, you will be able to:     

• Increase the number of job opportunities
• Create new business connections
• Gain competitive advantage
• Increase effectiveness and lower costs
• Offer expertise on improving work processes
• Offer safer and more efficient medical devices
• Increase customer satisfaction

• 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 in pursuing a career in Medical Devices Quality Management

There are no formal prerequisites for this ISO 13485 Foundation Course.

Being an ISO 13485-certified professional imposes your determination to offer qualitative products and services to your company and/or clients. Attaining the necessary knowledge and skills to operate an ISO 13485 framework demonstrates your commitment to helping your company ensure continuous improvement and better work processes.

It also indicates that you understand the importance of the safety and performance of medical devices and how a medical devices quality management system can assure just that, consequently leading to customer satisfaction.

Similarly, it can introduce you to new opportunities, such as working for large companies that offer quality products and services. These companies will value your knowledge and expertise on this standard while enabling you to maximize your earning potential.

Achieving the ISO 13485 Foundation certification opens up various career opportunities in the medical device industry, such as:

1. Quality Assurance Specialist: Ensuring compliance with quality standards.
2. Regulatory Affairs Specialist: Managing regulatory compliance for medical devices.
3. Internal Auditor: Conducting audits to maintain standards.
4. Process Improvement Specialist: Enhancing operational efficiency.
5. Documentation Specialist: Managing quality-related documentation.
6. Consultant/Trainer: Advising on ISO 13485 implementation.
7. Project Manager: Overseeing product development in compliance.

These roles are crucial in ensuring products meet regulatory standards and improving organizational processes.

This course includes an examination that will solidify your understanding of ISO 13485 and allow you to demonstrate your knowledge. The exam follows this format:

• Number of questions: 40 questions
• Exam type: Multiple choice
• Duration: 1 hours
• pass mark:70%
• Closed book
• In case of exam failure, you can retake the exam within 12 months for free