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An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course

An Essential Overview

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved. Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

13 March 2025
+ 3 July 2025, 19 November 2025 »

from £549

Need help?  Enrol or reserve

Overview

The ISO 13485:2016 standard specifies requirements for a Quality Management System (QMS) where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Such medical device organisations can be involved in one or more stages of the life-cycle, including; design and development, production, storage and distribution, installation, or servicing of a medical device, and design and development or provision of associated activities such as technical support.

ISO 13485:2016 can also be used by suppliers or external parties that provide products, including QMS-related services to such organisations.

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved.

Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

This course will be useful as a refresher or for those new to the medical device industry.  

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of Attending

  • Understand the requirements of ISO 13485
  • Learn how to develop a Quality Management System (QMS)
  • Know your responsibilities
  • Comply with the regulatory requirements
  • Take part in workshop exercises to consolidate the knowledge gained

Who Should Attend

  • Quality managers
  •  Quality assurance personnel
  • Regulatory affairs managers
  • Internal and external auditors
  • Medical device designers and developers
  • All those who are involved with the implementation of the QMS

Enrol or reserve

Linda Garrod
Ivdeology

Linda Garrod is a Quality Specialist at IVDeology Ltd, based in Kent, UK. She brings her exceptional quality experience from 20 years within the medical device industry, to support manufacturers in the creation and continual improvement of Quality Management Systems, compliant with the demands of  ISO 13485, MDSAP and CE IVDR.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

13 March 2025

Live online

09:00-16:45 UK (London) (UTC+00)
10:00-17:45 Paris (UTC+01)
05:00-12:45 New York (UTC-04)
Course code 14553

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 06 Feb

View basket 

 
Not ready to book yet?

for 7 days, no obligation

3 July 2025

Live online

08:30-16:45 UK (London) (UTC+01)
09:30-17:45 Paris (UTC+02)
03:30-11:45 New York (UTC-04)
Course code 14804

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 29 May

View basket 

 
Not ready to book yet?

for 7 days, no obligation

19 November 2025

Live online

09:00-16:45 UK (London) (UTC+00)
10:00-17:45 Paris (UTC+01)
04:00-11:45 New York (UTC-05)
Course code 15082

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 15 Oct

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Germany

  • Farstar medical

United Kingdom

  • Almac Group

Enrol or reserve

Run An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Live online for your team

1 day

Typical duration

Pricing from:

  • GBP 450
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy