MedTech news round up January 2022
This month’s round up covers news from the European Parliament regarding IVDR, a notice for 3rd country IVD manufacturers from…
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MedTech news round up December 2021
This month’s round up covers the latest on Swiss Medtech’s import concerns in relation to Switzerland’s third country status, updated…
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MedTech news round up November 2021
This month’s round up covers a first-of-its-kind publication from the WHO, a collaboration between the FDA, Health Canada and the…
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Preparing your Premarket Submission for Device Software Functions
The FDA has recently published draft guidance regarding the content of premarket submissions for device software functions. The guidance provides…
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MedTech news round up October 2021
This month’s roundup covers MedTech updates from the EU & Switzerland, the latest guidance and resources published by the FDA,…
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MedTech news round up September 2021
Our September MedTech news covers the latest updates and guidance from Europe, the US & Canada, and Asia Pacific. Read…
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The changing landscape for FDA EUAs
An Emergency Use Authorisation (EUA) allows the FDA to protect the health of the US public against chemical, biological, radiological,…
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8 tips for producing effective MDR Technical Documentation
Producing effective Technical Documentation provides manufacturers with their own central information source regarding their medical device. Accurate Technical Documentation can…
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