2021 charity donation beneficiary: The Theodora Foundation
As the saying goes, “Laughter is the best medicine”. With this firmly in mind, the Theodora Foundation charity works to…
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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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MDR adherence | MDCG guidance for Clinical Affairs
Keeping track of the ongoing guidance for MDR adherence can be a time-consuming task. So to simplify your information-gathering process,…
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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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Risk Analysis v FMEA: How knowing the difference benefits your risk management
Authorities ask Legal Manufacturers to perform a Risk Analysis for their Medical Devices according to ISO 14971. However, the expectation…
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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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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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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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