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 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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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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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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Quality Culture & Quality Transformation | Congenius Whitepaper
A successful business must constantly adapt to a changing environment. Markets, economic and political frameworks, technology – they permanently undergo…
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MedTech news roundup | January 2024
Our January MedTech news covers a broad range of recent guidance and updates from the EU, Switzerland, the US &…
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