Presented by
Management Forum
The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). This course provides an introduction to the regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.
7 December 2023
from £299
The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). Regulations for medical device quality management systems include particular requirements for non-conformance, correction, corrective and preventative actions. These requirements relate to non-conformances identified through internal audits, external audits, routine processes, customer complaints vigilance and many other activities. Evidence of a QMS which deals with non-conformance and prevents recurrence is important and expected when demonstrating conformity with the regulations.
These requirements are defined in ISO 13485, the international standard for medical device quality management systems, as well as in 21 CFR 820 and other global regulations.
This course provides an introduction to these regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Please note that access to a copy of ISO 13485 would be beneficial to delegates attending this training. If you do not already have access to this through your organisation, please see below the ways to acquire it:
ISO 13485 - https://www.iso.org/standard/59752.html
This standard is also available from national standards organisations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.
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
7 December 2023
Live online
13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 14241
Until 02 Nov
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* 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.
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: