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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…
Congenius
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…
Congenius
Consultant Spotlight – Charlotte Berg
Charlotte Berg joined us in July last year as a Senior Consultant in Operations. In her Consultant Spotlight below, Charlotte…
Congenius
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…
Congenius
How to achieve successful quality improvement
Many quality improvement projects aim to enhance one or more processes to become more effective, efficient, or compliant – often…
Congenius
Leveraging Real-World Evidence in medical device regulatory submissions
Providing data from randomized controlled trials has long been considered the gold standard to demonstrate the safety and efficacy of…
Congenius
MedTech news roundup April 2022
This month’s roundup includes an update on the EU Commission’s joint implementation plan for IVDR, guidance from the MDCG on…
Congenius
The EU-Swiss MRA | One year on
Without an updated MRA having been produced by last year’s MDR deadline (26 May 2021), Switzerland became a third country…
Congenius
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