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ISO 13485 Foundation

Online Course

Training Deals

Summary

Price
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Study method
Online
Duration
Self-paced
Qualification
No formal qualification
Additional info
  • Tutor is available to students
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Overview

ISO 13485 Foundation Course Overview

The Knowledge Academy's ISO 13485 Foundation course introduces the updated 2016 version of the ISO 13485. This includes: Medical Devices Quality Management Systems - Requirements for Regulatory Purposes” - The international reference standard for quality systems for medical device manufacturers in regulatory systems across the globe. During this training experience, delegates will learn the goals and objectives of ISO 13485 and how to implement and manage a Medical Devices Quality Management System (MDQMS). Topics will cover MDQMS policy, processes, performance measures, management commitment, management review, internal audit, and continual improvement. The course aims to ensure that upon completion, delegates will understand the features and functionality of MDQMS, and be able to recognise the connection between ISO 13485 and other standards and regulatory frameworks.

Description

ISO 13485 Foundation Course Outline

The following topics will be taught during this course:

  • Basic principles of ISO 13485:2016
  • A step-by-step guide of ISO 13485:2016 requirements
  • Detailed explanations of each requirement and quality system links between the requirements
  • Implementation phases of the ISO 13485 framework
  • Improvement of Quality
  • Conducting an ISO 13485 certification audit

Who is this course for?

Anybody who would like to gain an understanding of the ISO 13485 standard.

Requirements

Who Should Attend the ISO 13485 Training Course?

This course is intended for:

  • Members of medical devices quality team
  • Auditors
  • Professionals from the medical device industry
  • Those involved in the implementation of the ISO 13485 standard
  • Those involved in operations related to a Quality Management System for Medical Devices

Prerequisites

There are no prerequisites for this course.

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Legal information

This course is advertised on reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

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