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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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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MedTech news roundup August 2023
Our August 2023 MedTech news roundup covers upcoming legislative changes for Post-Market Surveillance in the UK, updates from the EU…
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Off-The-Shelf software in medical devices | FDA guidance
The FDA has issued updated guidance on Off-The-Shelf software in medical devices. The document, which supersedes a previous version issued…
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MedTech news roundup July 2023
Our July 2023 MedTech news roundup covers the latest from Swiss Medtech on utilising FDA authorised medical devices in Switzerland,…
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Risk management for software
In our free whitepaper below, our Head of Quality Dr Dirk Hüber addresses the certain challenges and special aspects that…
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