MedTech news roundup January 2025
Our MedTech news roundup for January 2025 covers the amended IvDO, MedTech Europe’s 2024 Regulatory Survey results, the latest endorsement…
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Technical Documentation Whitepaper Series | Part 2
In Part 1 of our two-part whitepaper series on technical documentation: Technical Documentation Essentials we covered an outline of what…
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Technical Documentation Whitepaper Series | Part 1
Technical documentation (TD) is key to ensuring medical device safety, efficacy, and quality. As the cornerstone of regulatory compliance, it…
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MedTech news roundup November 2024
Our MedTech news for November 2024 covers MedTech Europe’s recommendations for EU Green Deal implementation, MDCG guidance on the regulatory…
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MedTech news roundup October 2024
Our MedTech news for October 2024 covers the EU Parliament resolution on MDR revision, MDCG guidance on IVD qualification and…
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MedTech news roundup September 2024
Our MedTech news for September 2024 covers new procedures from Swissmedic for submitting clinical trials applications, the latest from EMA…
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MedTech news roundup August 2024
Our MedTech news roundup for August 2024 includes the latest from Swissmedic on EU IVDR equivalence and Swissdamed respectively, and…
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How the AI Act, NIS 2, & Data Act will impact the EU medical devices regulatory landscape
Between August this year and September next year the regulatory environment in the EU regarding data will become more complex,…
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