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,…
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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…
Congenius
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
Congenius appoints Marc Friedli as new Head of Operations
We are delighted to announce that Marc Friedli has been appointed as our new Head of Operations. Since joining Congenius…
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…
Congenius
A Regulatory Guide to Post-Market Surveillance
Post-Market Surveillance (PMS) according to MDR 2017/745 and IVDR 2017/746 is a systematic process to continuously monitor the safety and…
Congenius
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
New leadership for Congenius
This year marks eight years since the founding of Congenius. Born from a passion for sharing knowledge, our current CEO…
Congenius