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Medical Devices Quality Management Systems

This interactive an engaging online course has been designed to provide an in depth understanding of ISO 13485:2016.


Trainingonline4U Ltd

Summary

Price
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£220 inc VAT (was £299)
Or £73.33/mo. for 3 months... Read more
Offer ends 14 April 2021
Study method
Online, self-paced
Duration
3 hours
Access to content
90 days
Qualification
No formal qualification
CPD
3 CPD hours / points
Additional info
  • Certificate of completion available and is included in the price

3 students purchased this course

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Overview

The publication of ISO 13485:2016 marked a turning point in Quality Management Systems, for those involved in the lifecycles of Medical Devices.

ISO 13485:2016 was written to support Medical Device manufacturers in designing Quality Management Systems (QMS) that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of Medical Devices, that are safe for their intended purpose. ISO 13485 was last reviewed in 2020, which maintained that the 2016 version was still current.

This interactive and highly engaging online course has been re-designed to provide an in-depth understanding of ISO 13485:2016 and its practical implications. Learners will discover new knowledge and skills through a range of interactive learning methods including scenarios and regular knowledge checks. On completion of this training, participants will be able to apply their knowledge to the development of an ISO 13485:2016 compliant Quality Management System and help maintain on-going certification for their organisation.

CPD

3 CPD hours / points
Accredited by The CPD Certification Service

Course media

Resources

Description

Course Contents:

Module 1- Intro to ISO 13485

What is a Medical Device?

Introduction to ISO 13485

Scope of ISO 13485

Key improvements from the 2003 version of the Standard

Module 2- Quality Management Systems (QMS)

QMS general requirements

What is an ISO 13485 compliant QMS?

QMS document requirements

Module 3- ISO 13485 practical implications

Management responsibilities

Resource management

Product realisation

Measurement, analysis and improvement

Module 4- Summary

Course summary

Knowledge consolidation- scenario

Knowledge check- exam

Who is this course for?

Explore the requirements of ISO 13485:2016 and how to apply this Standard in your own organisation. This course is suitable for anyone working in any phase of the Medical Device development life-cycle.

Career path

On completion of this training, participants will be able to apply their knowledge to the development of a ISO 13485:2016 compliant Quality Management System and help maintain on going certification for their organisation.

Questions and answers

Currently there are no Q&As for this course. Be the first to ask a question.

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