MedTech news roundup September 2024
Our MedTech news for September 2024 covers new procedures from Swissmedic for submitting clinical trials applications, the latest from EMA…
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MedTech news roundup August 2024
Our MedTech news roundup for August 2024 includes the latest from Swissmedic on EU IVDR equivalence and Swissdamed respectively, and…
Congenius
How the AI Act, NIS 2, & Data Act will impact the EU medical devices regulatory landscape
Between August this year and September next year the regulatory environment in the EU regarding data will become more complex,…
Congenius
MedTech news roundup July 2024
Our MedTech news roundup for July 2024 covers WHO’s announcement of MeDevIS, the EU AI Act, MDCG guidance on medical…
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Design Control for Software | An introduction
The number of regulations, standards, and guidance documents specific to software in or as a medical device (SiMD, SaMD) is…
Congenius
MedTech news roundup June 2024
Our MedTech news roundup for June 2024 includes the latest on Swissdamed, a fact sheet from MedTech Europe on new…
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How to start & grow a digital health startup: Congenius & USI Lugano publish latest collaboration
Driven by strength of innovation, the life sciences industry is one of the strongest industrial sectors in Switzerland. Digital health…
Congenius
MedTech news roundup May 2024
Our MedTech news roundup for May 2024 spans a new combined studies project from the EU Commission, new guidance from…
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