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ISO 13485:2016 Quality Management Systems for Medical Devices cover image

ISO 13485:2016 Quality Management Systems for Medical Devices
Integrity Clinical Compliance

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

Summary

Price
£299 inc VAT
Or £49.83/mo. for 6 months...
Study method
Online
Course format
Reading material
Duration
3 hours · Self-paced
Access to content
90 days
Qualification
No formal qualification
Certificates
  • Certificate of completion - Free
Assessment details
  • End of course exam (included in price)
4 students purchased this course

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Overview

The publication of ISO 13485:2016 marked a significant advancement in Quality Management Systems (QMS) for organisations involved in the lifecycle of medical devices. Specifically designed to support medical device manufacturers, this standard provides a robust framework for establishing and maintaining effective processes to ensure the consistent design, development, production, installation, and delivery of medical devices that are safe and fit for their intended use. A formal review in 2020 confirmed that the 2016 version remains current and valid.

This expertly developed, interactive online course – updated in 2026 – offers a comprehensive exploration of ISO 13485:2016 and its practical application in real-world settings. Learners will build their knowledge through engaging, scenario-based activities and interactive content designed to reinforce key concepts.

Upon successful completion, participants will be equipped to contribute to the development, implementation, and maintenance of an ISO 13485:2016-compliant Quality Management System and support continued regulatory compliance and certification within their organisation.

Certificates

Assessment details

End of course exam

Included in course price

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 lifecycle.

Career path

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 ongoing certification for their organisation.

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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.

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.
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