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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MedTech news roundup June 2023
Our June 2023 MedTech news roundup includes Swissmedic’s Annual Report findings, updates from the MHRA on regulatory reform in the…
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Guide for start-ups – Regulatory Affairs & Design Assurance essentials
Start-ups that want to bring a medical device to market are inevitably confronted with a plethora of questions regarding compliant…
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Cybersecurity for medical devices
Medical devices are often connected to networks and can be vulnerable to cyber-attacks, which can compromise patient safety and the…
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MedTech news roundup May 2023
Our May 2023 MedTech news roundup includes Swiss Medtech’s position paper on medical device procurement for the Swiss population, Swissmedic’s…
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