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risk assessment

September 3, 2025

ISO 10993-1 FDIS Updates: FAQ from the Panel Q&A

ISO 10993-1 guides the biological evaluation of medical devices. With the Final Draft International Standard (FDIS) approved, this update is one of the most significant in recent years. The panel covered what is changing and how to prepare. This FAQ...

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August 28, 2025

Requirements from the New ISO 10993-1 Revision for Risk Assessment Authors

One of the core tenets of ISO 10993-1 is the risk-based approach for determining the safety of a medical device. In the new revision of the standard there is an emphasis on the qualifications of the people performing the evaluations...

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