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MedTech news round up April 2021
Our April MedTech news covers a round up of the latest updates and information from the EU Commission, MDCG, FDA,…
Congenius
A guide to 513(g) requests with the FDA
A 513(g) request for information is a means for medical device manufacturers to obtain information about the FDA’s views regarding…
Congenius
Celebrating 5 years of Congenius
This month marks the 5th Anniversary of Congenius. Born from a passion for sharing knowledge, Congenius was founded in 2016…
Congenius
Congenius launches Clinical department with Dr Barbara Widmann at the helm
We are very excited to announce the launch of our new Clinical department, led by Dr Barbara Widmann. As the…
Congenius
MedTech news round up March 2021
Our MedTech news for March 2021 covers MDR updates from Europe & the UK, an insightful piece on leveraging real-world evidence in regulatory…
Congenius
Consultant Spotlight – Dr Silvio Peng
Dr Silvio Peng joined us in October 2020 as a Consultant in Operations. Microbiologist, biocompatibility specialist, sports fan and owner…
Congenius
3 steps to Classifying Medical Devices in the US
The process of classifying a medical device in the US involves reviewing the potential regulatory class (I, II or III),…
Congenius
3 steps to Classifying Medical Devices in the EU
To classify a medical device in the EU, the intended use needs to be articulated, before defining and categorising the…
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