The seminar “Sterile packaging rethought: Safe, simple and compliant handling”, which had to be postponed several times due to the Corona situation, will be held on 12.05.2022 in Cologne.

Content

With the publication of ISO 11607-1 “Packaging for medical devices to be sterilized in the final packaging – Part 1: Requirements for materials, sterile barrier system and packaging systems” in February 2019, the topic of usability was also added to the list of requirements for sterile packaging of medical devices.

The new standard defines specific requirements for usability evaluation for aseptic presentation in Chapter 7. Apart from a note that the evaluation should take place under real or simulated conditions and that formative and summative studies are an appropriate means of choice, the standard does not provide any process-specific or practical implementation guidance. Instead, the standard refers to the FDA Human Factors Guidance and IEC 62366-1.

Use-Lab GmbH, as an interdisciplinary and methodologically experienced team, has addressed the issue and developed specific solutions to achieve compliance with the standard.

In cooperation with the Forum Institut, Use-Lab offers a 1-day seminar on 12.05.2022 at the Dorint Hotel am Heumarkt in Cologne, in which our project managers Lars-Oliver Jansen and Thore Reitz, will talk about the current regulatory requirements, basic information on the topic of usability and packaging as well as an exciting practical part with solution approaches.

Info and booking:
https://www.forum-institut.de/seminar/22052301-sterilverpackung-neu-gedacht