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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MedTech news roundup July 2024
Our MedTech news roundup for July 2024 covers WHO’s announcement of MeDevIS, the EU AI Act, MDCG guidance on medical…
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MedTech news roundup June 2024
Our MedTech news roundup for June 2024 includes the latest on Swissdamed, a fact sheet from MedTech Europe on new…
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A Regulatory Guide to Post-Market Surveillance
Post-Market Surveillance (PMS) according to MDR 2017/745 and IVDR 2017/746 is a systematic process to continuously monitor the safety and…
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MedTech news roundup May 2024
Our MedTech news roundup for May 2024 spans a new combined studies project from the EU Commission, new guidance from…
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MedTech news roundup April 2024
Our April 2024 MedTech news roundup covers an update from Swissmedic on medical device software, guidance from the MDCG regarding…
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