Presented by
Management Forum
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.
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.
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:
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
Until 06 Feb
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
Until 29 May
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
Until 15 Oct
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
United Kingdom
1 day
Typical duration
Pricing from:
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: