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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…
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…
Congenius
MDSAP – When to join the program
Based on ISO 13485:2016, MDSAP (Medical Device Single Audit Program) is an audit program that allows for a single regulatory…
Congenius
MedTech news round up February 2021
Our MedTech news for February 2021 covers the EU Commission’s new information on the management of legacy devices and IVDs,…
Congenius
Consultant Spotlight – Leah Kidney
Leah Kidney is one of our valued consultants in Quality. She’s also an ex-Gaelic Football star, keen traveller and aspiring…
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