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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,…
Congenius
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…
Congenius
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…
Congenius
MedTech news round up August 2021
Our August MedTech news covers the latest updates, guidance and position papers from the US & Canada, Europe & Switzerland,…
Congenius
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…
Congenius
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…
Congenius
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…
Congenius
What Biden’s Executive Order means for medical device cybersecurity
This year on May 12, the Biden administration passed an Executive Order on improving cybersecurity in the US, with the…
Congenius
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