Description

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 gain "Certified ISO 13485 Foundation' Certification. This Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.

About This Course

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

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

Assessment

Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 40 question, multiple choice exam on Day 2 of the course. The overall passing score is 70%, to be achieved within the 60 minute time allowance.

Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success.

Prerequisites

None

What's Included?

Certification fees are included on the exam price

Training material containing over 200 pages of information and practical examples will be distributed

An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.

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

Accreditation

Provided by

This course is Accredited by NACS and Administered by the IECB

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ISO 13485 Quality Management Foundation

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