Congenius appoints Dr Sarah Bosshard as new Head of Clinical
We are delighted to announce that Dr Sarah Bosshard has been appointed as our new Head of Clinical. Since joining…
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MedTech news roundup March 2025
Our March MedTech news covers EU-US trade tensions, the Clean Industrial Deal, updated guidance on IVD classification, and calls for…
Congenius
MedTech news roundup February 2025
Our February MedTech news covers calls from the European MedTech industry for the EU to become a full member of…
Congenius
MedTech news roundup January 2025
Our MedTech news roundup for January 2025 covers the amended IvDO, MedTech Europe’s 2024 Regulatory Survey results, the latest endorsement…
Congenius
MedTech news roundup November 2024
Our MedTech news for November 2024 covers MedTech Europe’s recommendations for EU Green Deal implementation, MDCG guidance on the regulatory…
Congenius
MedTech news roundup October 2024
Our MedTech news for October 2024 covers the EU Parliament resolution on MDR revision, MDCG guidance on IVD qualification and…
Congenius
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…
Congenius
Clinical evaluation under MDR | Determining adequate clinical evidence
The introduction of MDR has significantly increased the importance of clinical evaluation for medical devices. And whilst several guidelines exist…
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