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Starting 12 October 2020

4-week online academy

Effectively prepare for your audit under the harmonised ISO 13485:2016 and MDSAP

Course Overview

The publication of ISO 13485:2016 marked a turning point in Quality Management Systems for those involved in the life-cycles of medical devices in the EU. The deadline for compliance was March 2019, however in addition to this, the FDA have recently announced their plans to harmonise their Quality System regulations under the Medical Device Single Audit Programme (MDSAP) with ISO 13485:2016, so organisations under the FDA meet both domestic and international requirements.

This essential 7 module course will allow you to understand the increased requirements around risk management under the 2016 revision and to familiarise yourself completely with ISO 13485:2016. In addition, delegates will gain practical knowledge and key skills in conducting audits under ISO 13485 in conjunction with the most recent MDSAP auditing model, complemented with real-life case studies.

If you would like to start the course sooner than advertised simply get in contact with our training consultants by emailing and we will arrange this for you as soon as possible.

Online Academies

MDTI online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.

Over 4 weeks students will learn through:

  • 7 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisiting the content with unlimited access to all the materials for 3 months
  • Participating in the discussion forum to interact with other students
  • Interacting with the trainer through the forum during the course
  • Additional content such as materials and white papers available to download

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact

What will you learn?

Documentation structure
Documentation structure

Understand documentation structure required by the Standard

Documentation control
Documentation control

Investigate best practice for document control

Management responsibility & resource management
Management responsibility & resource management

Examine management responsibility and resource management requirements

Product lifecycle
Product lifecycle

Explore product realisation from the design process to manufacturing


Understand validation of aspects of manufacturing process

Data management
Data management

Gather and analyse data using internal audits and corrective action processes

Medical Device Single Audit Programme (MDSAP)
Medical Device Single Audit Programme (MDSAP)

Gain an in-depth review of the MDSAP and explore the country-specific aspects of it

MDSAP assessments
MDSAP assessments

Review audit guidance for MDSAP assessments

Case studies
Case studies

Cement your knowledge through MDSAP assessment case studies

Who is this course for?

This course will be useful for anyone considering the application of ISO 13485:2016, or who needs an overview of Quality Management Systems for medical devices. It will be applicable for professions in:

  • Quality
  • Engineering
  • Product design
  • Regulatory affairs

On average, delegates of our online academies said...

for quality of content
applied content during the course to their role
for quality of delivery

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

25% discount on Routledge books

As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website

Examples of books and eBooks within medical devices include:

  • ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition
  • ISO 9001: 2015 - A Complete Guide to Quality Management Systems
  • Medical Device Quality Assurance and Regulatory Compliance
  • Design Controls for the Medical Device Industry, Third Edition
  • And more