Congenius Whitepaper | Overcoming the challenges of regulating combination products
Combination products have existed in both the EU and the US markets for several decades, but regulations for combination products…
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EUDAMED roundup | What’s happened and what’s next
The creation of a European database for registering certified medical devices is regarded as a cornerstone of the EU MDR…
Congenius
MedTech news roundup July 2022
Our July MedTech news roundup includes an IVD notification FAQ from Swissmedic, MDCG guidance on interim solutions for IVDR in…
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How to calculate the Analytical Evaluation Threshold for your Biocompatibility Assessment
The Analytical Evaluation Threshold (AET) is the crucial parameter for demonstrating that your analytical results sufficiently assess the biological safety…
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How to develop SaMD | Congenius whitepaper
As health care advances, software has become integrated widely into digital ecosystems that serve both medical and non-medical purposes. To…
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MedTech news roundup June 2022
Our June MedTech news roundup includes a notice from the EU Commission on the EU-Swiss MRA status for IVDs, advice…
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Consultant Spotlight – Charlotte Berg
Charlotte Berg joined us in July last year as a Senior Consultant in Operations. In her Consultant Spotlight below, Charlotte…
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MedTech news roundup May 2022
This month’s MedTech news includes guidance from the MDCG on significant changes under IVDR, new ordinances from the Swiss Federal…
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