ISO 13485 Foundation Overview
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.
Who Should Attend?
- 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
Professional and Organizational Impact
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
Upcoming Sessions
Next available dates worldwide
Examination & Certification Information
Recognized credentials that advance your career
Participants who complete the ISO 13485 Foundation Program earn a Trainingcred Certificate of Achievement, demonstrating professional competence and alignment with global standards in learning and development.
NITA Accredited
Accredited by the National Industrial Training Authority, ensuring programs meet nationally recognized standards of quality and relevance.
CPD Certified
Recognized by the CPD Certification Service, ensuring every program meets internationally benchmarked standards of professional excellence.























