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Consultant Spotlight – Marc Friedli
Marc Friedli joined us in January 2021 as a Senior Consultant in Operations. Process engineer, production specialist, bass guitarist and…
Congenius
How UKCA will impact Swiss medical device approval in Great Britain
The UK’s exit from the European Union brought with it Britain’s withdrawal from the scope of application of the EU…
Congenius
MedTech news round up June 2021
Our MedTech news for June 2021 includes an update on the EU-Swiss MRA, the latest guidance documents from the FDA…
Congenius
How to determine legitimate FDA approval
Within the medical devices field, you may have come across terms like “FDA registered”, “FDA certified” and “FDA Registration Certificate”.…
Congenius
EU-Swiss MRA latest: How MDR & lack of MRA update affect medical devices trade
Until now, Switzerland and the EU have relied on a specific chapter of the Mutual Recognition Agreement (MRA) for trade…
Congenius
MedTech news round up May 2021
Our May MedTech news includes timely updates from the US and EU, links to recent notable documents from the MDCG…
Congenius
Is my software SaMD?
As health care advances, software has become integrated widely into digital ecosystems that serve both medical and non-medical purposes. Our…
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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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