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”.…
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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…
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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…
Congenius
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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