Keep calm and be ready for the new ISO 10993-1

This webinar will provide an in-depth analysis of the upcoming changes in ISO 10993-1, focusing on the key updates compared to the 2018 version. ISO 10993-1 is a critical standard used to assess the biological safety of medical devices, and the revision is ready to be published as FDIS. The presentation will highlight significant revisions to the structure, scope, and definitions.

The session will explore the enhanced risk management process, which now emphasises assessment throughout the device lifecycle. The proposed new categorisation of devices will be discussed. The webinar will discuss the implications of these changes for manufacturers, offering practical recommendations for adapting internal processes and ensuring compliance with the new standard.

Join us to stay informed on the latest developments in ISO 10993-1 and how these changes can affect your approach to biological evaluation in medical device development.

German session: Anmeldung

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