PECB ISO 13485 Foundation – Live Online

ISO 13485 Foundation

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).

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