New AI Insights in EU Healthcare: Opportunities & Challenges
Healthcare systems are facing a rising demand due to aging populations, an increase in chronic and complex conditions, growing…
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UDI Registration in Swissdamed: Key Insights and Deadlines
With economic operator registration in the Actor module of Swissmedic’s Swissdamed database in force for…
Swissmedic Guidance Regarding System & Procedure Packs
Swissmedic has issued a new guidance document outlining the obligations for the assembly and labelling of systems and…
New EU Regulation on eIFUs Adopted by Swissmedic
Swissmedic has adopted EU Commission Implementing Regulation (EU) 2025/1234, which extends the scope of electronic…
Notified Body Proposed Reform: EU Medical Device Governance
The EU medical device regulatory landscape is at a critical juncture, as concerns grow over fragmented implementation and the…
EUDAMED Registration Webinar for MDR & IVDR
Navigating EUDAMED: Streamlined Compliance for EU MDR & IVDR Success We hosted a webinar on navigating EUDAMED and understanding…
FDA MDUFA 2026: Fees & Relief Update
Effective October 1, 2025, the FDA has increased the annual establishment registration fee by 23% under the Medical Device…
Top Errors When Importing Medical Devices into Switzerland
In regard to importing medical devices into Switzerland under the former Mutual Recognition Agreement (MRA) with the European Union…
Expansion of Mexico’s Regulatory Pathway for Medical Devices
Mexico’s expedited regulatory medical device pathway, known as the Equivalence Route, was previously limited to recognizing marketing authorizations issued…
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