Software in Medical Devices, by MD101 Consulting

To content | To menu | To search

Tag - IEC 81001-5-1

Entries feed - Comments feed

Friday, 8 March 2024

Templates: Security Risk Management Plan and Security Risk Assessment Report

Cybersecurity guidances and standards have quite evolved the last few months.
It's time to push new templates!

Continue reading...

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?

Continue reading...

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.

Continue reading...

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?

Continue reading...