Software in Medical Devices, by MD101 Consulting

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Tag - IEC 81001-5-1

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Friday, 23 February 2024

IEC 81001-5-1 Right Here Right Now

IEC 81001-5-1 is now the standard for cybersecurity in medical devices. But is this standard asking too much for?

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Friday, 6 October 2023

Final 2023 FDA Premarket Cybersecurity guidance released

The final version of the FDA guidance titled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions was published the 27th September 2023.

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Monday, 20 February 2023

Maintained software, Supported software, Required software, and SOUP

These three concepts come from IEC 62443 and were adopted in IEC 80001-5-1. SOUP isn't present in IEC 81001-5-1.
What are the differences between SOUP and Maintained software, Supported software, and Required software?

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