Overcoming the regulatory challenges to achieve global market access
Global regulatory requirements for medical devices differ widely in scope and interpretation. These disparities can delay product launches, elevate compliance…
Congenius
Global regulatory requirements for medical devices differ widely in scope and interpretation. These disparities can delay product launches, elevate compliance…
Congenius
Our MedTech news for April 2026 covers updates on device classification and the expansion of WET devices under the EU…
Congenius
Our March 2026 MedTech news covers the latest on the EU / Swiss MRA, Team-NB’s thoughts on the MDR /…
Congenius
Our MedTech news for February 2026 covers further evolution for global device regulation – with new EU harmonised standards, a…
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Welcome back – and Happy New Year from our Congenius Knowledge Team! Our MedTech roundup for January 2026 kicks off…
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Our November 2025 MedTech news brings you the latest on the EU Commission’s Digital Omnibus proposal, calls for EU reference…
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Our October MedTech news roundup covers new harmonised standards from the EU Commission, the latest on swissdamed, and guidances from…
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Our September 2025 MedTech news covers the latest regulatory updates from the EU, Switzerland, China, Canada, and Brazil. Find out…
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