Presented by
Management Forum
Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.
28 November 2023
from £299
Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state, including maintaining this state for a defined period of time. These regulatory requirements relate to general safety and performance aspects of the products, and the requirements for independent, third-party conformity assessment of the processes for achieving and maintaining sterility. Evidence of an appropriate and stable sterile barrier system is important and expected when demonstrating conformity with the regulations.
These requirements are supported by a series of standards for maintaining sterility over time with appropriate sterile barrier systems.
This course provides an introduction to these regulatory requirements, as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.
This course is part of our GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.
Please note that delegates will require access to a copy of ISO 11607-1 to gain the most from this training. If you do not already have access to this through your organisation, please see below the ways to acquire it:
ISO 11607-1 - https://www.iso.org/standard/70799.html
This standard is 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
28 November 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 14239
Until 24 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: