ISO 10993-1:2025 | What’s new in the revised standard?
Back in June, our Senior Operations Consultant and Biocompatibility Specialist Dr. Silvio Peng shared five important updates from the draft ISO…
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ISO 10993-1 | What’s new in the latest draft standard?
ISO 10993-1 provides the governing foundation for the biological evaluation of medical devices, explaining the fundamental requirements and general principles.…
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Chemical Analysis for Biocompatibility Assessment of Medical Devices | Essentials from the FDA draft guidance
In September 2024, the FDA published its draft guidance on “Chemical Analysis for Biocompatibility Assessment of Medical Devices” to improve…
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Biocompatibility & Cleanliness Testing for Medical Devices
In the realm of medical technology and innovation, the development and production of safe and effective medical devices is of…
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Transferring your manufacturing site | What to consider regarding biocompatibility
Whether for economic or strategic reasons, medical device manufacturers often outsource their production to another site or external company. In…
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How to calculate the Analytical Evaluation Threshold for your Biocompatibility Assessment
The Analytical Evaluation Threshold (AET) is the crucial parameter for demonstrating that your analytical results sufficiently assess the biological safety…
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Key learnings from ISO 10993-23:2021: Biological evaluation of medical devices – Tests for irritation
ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation assesses the possible contact hazards from medical…
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Cobalt in medical devices: Do the benefits outweigh the risks?
In 2017, cobalt was up-classified by the European Chemicals Agency (ECHA) with respect to its carcinogenic, reproductive toxicity and mutagenic…
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