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ISO 13485 Foundation Self-study with PECB Exam 2 Attempts Included. – New Course Offer

  • Certification fees are included on the exam price
  • Training material containing over 450 pages of information and practical examples will be distributed
  • Online access to courseware slides via MyPECB platform
  • Lifetime 24×7 online access to PECB course materials
  • A participation certificate of 16
  • CPD (Continuing Professional Development) credits will be issued
  • In case of exam failure, you can retake the exam within 12 months for free

  • FormatSelf-Study
  • ExamExam included (2 attempts)

Overview

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).

Certification:

After successfully completing the ISO 13485 Foundation exam, you can apply for the credential shown on the table below.

The certificate requirements for the ISO 13485 Foundation are:

Designation Training Course Exam Professional experience MS audit/assessment experience BCMS project experience Other requirements
PECB Certificate Holder in ISO 13485 Foundation PECB ISO 13485 Foundation Pass the PECB ISO 13485 Foundation Exam None None None Signing the PECB Code of Ethics

Delivery Format

  • Format: Self-Study

Examination and Certification

  • Exam: Exam included (2 attempts)

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