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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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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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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How will the EU Green Deal impact the medical device industry?
The European Green Deal is a set of policy initiatives on climate action laid out by the EU Commission that…
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How to choose the right QMS
Whether you’re part of a large, well-established company with an existing Quality Management System, or involved in a start-up that’s…
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Transferring your manufacturing site | What to consider regarding biocompatibility
Whether for economic or strategic reasons, medical device manufacturers often outsource their production to another site or external company. In…
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NIS 2 Directive | What it means for healthcare, pharma, and manufacturers of medical devices
On 27 December 2022, Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the EU (NIS…
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