Presented by
Management Forum
Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.
★★★★★ "Very structured training at perfect pace, covering all important point. Very good interaction."
19-20 October 2023
from £1299.00
Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations.
These requirements have been supported by a portfolio of standards on:
This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.
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 delegates will require access to copies of ISO 11135 and ISO 11137-1 in order to take part in the exercises. If you do not already have access to these through your organisation, please see below the ways to acquire them:
ISO 11135 - https://www.iso.org/standard/56137.html
ISO 11137-1 - https://www.iso.org/standard/33952.html and amendment at https://www.iso.org/standard/72106.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
19-20 October 2023
Live online
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 12779
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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.
Very structured training at perfect pace, covering all important point. Very good interaction.
Jun 1 2023
Marijana Jelecevic Kakouros
RA Manager, Beckton Dickinson
Jun 1 2023
An excellent webinar that delivered above and beyond. Eamonn would be a great contact to keep for the future. His knowledge is top class.
Kerry Poole
Mercian Surgical Co Ltd
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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: