ISO 13485 Foundation

How will you benefit from this course?

You will be able to understand the basic concepts and principles of a Medical Devices Quality Management System (MDQMS) based on ISO 13485. Additionally, 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.

Once you complete the course, you can sit for the exam and, if you successfully pass it, you can apply for the “PECB Certified ISO 13485 Foundation” credential. A PECB Foundation certificate proves that you have comprehended the fundamental methodologies, requirements, guidelines, framework and managerial approach.

Are you one of these?

• Individual involved in Medical Devices Quality Management
• Individual seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
• Individual 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

Prerequisites

None

ISO 13485 Foundation

The Two-day Agenda

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

ISO 13485 Foundation

Examination

The exam covers the following competency domains:

Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Domain 2: Medical Devices Quality Management System (MDQMS)

For more information about exams, please visit Examination Rules and Policies.

ISO 13485 Foundation

Certification

Once you pass the exam, you will be able to apply for the credential appropriate to your own experience. For more information about ISO 13485 certifications and the PECB certification process, please refer to the Certification Rules and Policies.

ISO/IEC 27701 Foundation

General Information

• Your exam price includes all certification fees
• You will receive over 200 pages of information and practical examples
• You will be issued a participation certificate of 14 CPD (Continuing Professional Development) credits once you complete the course
• If you are unable to pass the certification exam, you can retake the exam within 12 months for free

Quick Link:

ISO 13485 Foundation Course Brochure