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Sustainability in plastics manufacturing for medical devices
Sustainability remains one of the most complex challenges facing the MedTech industry. It’s a broad, often polarising topic, and many…
Congenius
2025 – that’s a wrap!
It’s been an exciting and rewarding year at Congenius. As we navigated 2025, our team achieved a number of meaningful…
Congenius
EU proposed MDR & IVDR update | What’s in the proposal?
On 16 December 2025, the European Commission published a proposal to amend the EU regulatory framework for medical devices and…
Congenius
Charity beneficiary 2025 | Insulin for Ukraine
In Switzerland, insulin is readily available. In Ukraine, this hasn’t been the case since 24 February 2022. So, this year,…
Congenius
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
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