ISO 13485 Foundation
Why should you attend?
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.
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
What is included in PECB ISO 13485 Foundation Course material
- Lecture sessions are illustrated with practical questions and examples
- Practical exercises include examples and discussions
- Practice tests are similar to the Certificate Exam
PECB ISO 13485 Foundation Exam Format
Exam Type: Multiple Choice & Closed Book
Number of Exam Questions: 40
Exam Duration in Hours: 1
Prerequisites
None
Course 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
- Please note all PECB certifications activities must be completed within 12 months from date of enrollment by SMATICA. This includes (take the PECB exam (1st attempt), retake the exam (2nd attempt, if needed), apply for the PECB certificate, and be certified).
