Presented by
Management Forum
The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself, and are critical to the safety and performance of the device and to compliance with regulatory requirements. This course provides an introduction to the regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.
5 December 2023
from £299
The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself and are critical to the safety and performance of the device and to compliance with regulatory requirements. Regulations for medical devices include particular requirements for labelling and the provision of Instructions for Use. These regulatory requirements relate to general safety and performance aspects of the products, and the requirements for clear and unambiguous information to be supplied to clinicians, patients and other users. Evidence of labelling which includes all required information is important and expected when demonstrating conformity with the regulations.
These requirements have been supported by a portfolio of standards, regulations and guidance documents on:
This course provides an introduction to these regulatory requirements as they relate to the labelling of medical devices 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 copies of ISO 15223-1 and ISO 20417 would be beneficial to delegates attending this training. If you do not already have access to these through your organisation, please see below the ways to acquire them:
ISO 15223-1 - https://www.iso.org/standard/77326.html
ISO 20417 - https://www.iso.org/standard/67943.html
These standards are also available from national standards organizations 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
5 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 14240
Until 31 Oct
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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: