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How real-world evidence can strengthen your clinical strategy
Used in diverse real-world settings, medical devices often undergo rapid iterations – encountering varying levels of operator skill within changeable…
Congenius
MedTech news roundup September 2025
Our September 2025 MedTech news covers the latest regulatory updates from the EU, Switzerland, China, Canada, and Brazil. Find out…
Congenius
MedTech news roundup Summer 2025
Our summer MedTech roundup gathers the latest in industry news from July and August from regulators around the world. Find…
Congenius
How to maintain an effective QMS
Maintaining an efficient and effective Quality Management System (QMS) over time is a substantial challenge. But what makes it so…
Congenius
How will the EU Packaging & Packaging Waste Regulation (PPWR) impact the medical device industry?
The European Union’s Packaging and Packaging Waste Regulation (PPWR) represents a cornerstone in the EU’s broader environmental and circular economy…
Congenius
MedTech news roundup June 2025
Our June 2025 MedTech news covers the recent guidance from the MDCG on the interplay between the MDR/IVDR and the…
Congenius
ISO 10993-1 | What’s new in the latest draft standard?
ISO 10993-1 provides the governing foundation for the biological evaluation of medical devices, explaining the fundamental requirements and general principles.…
Congenius
MedTech news roundup May 2025
Our May 2025 MedTech news covers the Swiss Federal Council’s guidelines for expanding medical devices supply, an upcoming focus campaign…
Congenius
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