Presented by
Management Forum
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.
★★★★★ "I really liked the webinar, I have no complaint about it, just keep it up. The best for me was that ... more"
3 July 2025
+ 19 November 2025 »
from £649
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
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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.
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
This course will cover:
Overview of ISO 13485:2016
- Introduction to standards and their use
- Use of ISO13485:2016
- Conformity assessment
- Cost/Benefit of Quality
Defining the Scope and Objectives of Your QMS
- Quality policy
- Quality objectives
- Quality manual
Documentation Requirements
- Requirements
- Document control
- Resource management
- Training
Workshop Exercise: Writing Quality Policy and Objectives
Intellectual Property (IP) to CE Marking in a QMS
- Design and development
Supplier Management
- Economic Operators
- Supplier management
- Supply chain control
Direct Processes
- Change management
- Risk Management
- Control of non-conforming product
Post Market Surveillance
- What is it?
- The elements
- Reactive vs Proactive
Workshop Exercise: Quality Management - Functional Interaction
Summary and Key Take Aways
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.
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
3 July 2025
Live online
09:00-16:45 UK (London) (UTC+01)
10:00-17:45 Paris (UTC+02)
04:00-11:45 New York (UTC-04)
Course code 14804
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 29 May
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 15 Oct
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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.
Reviews of IPI's An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices training course
I really liked the webinar, I have no complaint about it, just keep it up. The best for me was that [speaker] is always open for questions; if there's any doubt about the topic explained.
Mar 13 2025
Daniel Gutierrez 
Quality corporate, ISDIN
Germany
- Farstar medical
Greece
- PPD, part of Thermo Fisher Scientific
Ireland
- Siemens Healthineers
Spain
- ISDIN
United Kingdom
- Almac Group
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 500
- 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:
