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ISO 10993-1:2025 | What’s new in the revised standard?
Back in June, our Senior Operations Consultant and Biocompatibility Specialist Dr. Silvio Peng shared five important updates from the draft ISO…
Congenius
MedTech news roundup November 2025
Our November 2025 MedTech news brings you the latest on the EU Commission’s Digital Omnibus proposal, calls for EU reference…
Congenius
Risk Analysis vs FMEA – What’s the difference?
According to ISO 14971, legal manufacturers are required to perform a Risk Analysis for their medical devices. However, the expectation is that…
Congenius
MedTech news roundup October 2025
Our October MedTech news roundup covers new harmonised standards from the EU Commission, the latest on swissdamed, and guidances from…
Congenius
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…
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