Consultant Spotlight – Caroline Bachem
Zurich-born Caroline Bachem is one of our up-and-coming Junior Consultants in our Operations team. Caroline started out in the MedTech…
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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,…
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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…
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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…
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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…
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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…
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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…
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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),…
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