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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MedTech news round up August 2021
Our August MedTech news covers the latest updates, guidance and position papers from the US & Canada, Europe & Switzerland,…
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Congenius welcomes Corinne Larke as new Head of Regulatory
We are delighted to welcome our new Head of Regulatory to the Congenius team. Corinne Larke joins us following over…
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MedTech news round up July 2021
Our July MedTech news covers the latest from the EU commission on harmonised standards under MDR, FDA’s recent efforts to…
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Is a decentralized approach the future for clinical trials?
A decentralized clinical trial (DCT) is a trial where subject recruitment, delivery and administration of study medication and collection of…
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