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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In September we shared an article from our Head of Quality Dr Dirk Hüber on the purpose and methodology differences…
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Authorities ask Legal Manufacturers to perform a Risk Analysis for their Medical Devices according to ISO 14971. However, the expectation…
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An Emergency Use Authorisation (EUA) allows the FDA to protect the health of the US public against chemical, biological, radiological,…
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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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A decentralized clinical trial (DCT) is a trial where subject recruitment, delivery and administration of study medication and collection of…
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This year on May 12, the Biden administration passed an Executive Order on improving cybersecurity in the US, with the…
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The UK’s exit from the European Union brought with it Britain’s withdrawal from the scope of application of the EU…
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