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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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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Design Control for Software | An introduction
The number of regulations, standards, and guidance documents specific to software in or as a medical device (SiMD, SaMD) is…
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MedTech news roundup March 2024
Our March 2024 MedTech news roundup covers new guidance from the MDCG on clinical investigation plan content, an update from…
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MedTech news roundup | February 2024
Our February 2024 MedTech news roundup covers the latest information from the MDCG on EMDN update procedures and the vigilance…
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MedTech news roundup November 2023
Our November 2023 MedTech news roundup covers guiding principles on PCCPs, information from Swissmedic on vigilance reports for medical devices,…
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MedTech news roundup October 2023
Our October 2023 MedTech news roundup covers the Swiss Federal Council’s amendment to MedDO and the EU Commission’s Q&A on…
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MedTech news roundup September 2023
Our September 2023 MedTech news roundup includes updates from Swissmedic on Swissdamed, from the EU Commission regarding the extended MDR…
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