MedTech news roundup – January 2023
Our January 2023 MedTech news roundup covers the latest from Swissmedic regarding its strategic goals for 2023-2026 and advice on…
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MedTech news roundup – November 2022
Our November MedTech news roundup covers the recent Swiss-UK MRA, Swiss Parliament’s mandate to the Federal Council to adapt national…
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MedTech news roundup – October 2022
Our October MedTech news roundup includes the latest from the EU Commission on clinical evaluation assessment reports and specifications for…
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MedTech news roundup September 2022
Our September MedTech news roundup includes information from Swiss Medtech regarding increasing cost pressure on medical device manufacturing, findings from…
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MedTech news round up August 2022
Our August MedTech news roundup covers the EU Commission’s call for EURLs, an FAQ from Swissmedic on medical devices notification,…
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Addressing the latest Cybersecurity legislation for medical devices
Many existing medical devices operate on legacy systems, which makes them difficult to maintain and vulnerable to manipulation by hackers.…
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Congenius Whitepaper | Overcoming the challenges of regulating combination products
Combination products have existed in both the EU and the US markets for several decades, but regulations for combination products…
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MedTech news roundup July 2022
Our July MedTech news roundup includes an IVD notification FAQ from Swissmedic, MDCG guidance on interim solutions for IVDR in…
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