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Friday, 13 December 2024
By Mitch on Friday, 13 December 2024, 10:03 - Templates
The templates present on this site deserve a refresh. We end the 2024 updates with version of the Software Configuration Management Plan and Usability Engineering File.
Friday, 4 October 2024
By Mitch on Friday, 4 October 2024, 14:00 - Standards
A new standard is being drafted by the IEC. Its ID will be IEC 81001-5-2 and title: Health software and health IT systems safety, effectiveness and security – Part 5-2: Security Risk Management for Manufacturers.
Friday, 8 March 2024
By Mitch on Friday, 8 March 2024, 13:47 - Templates
Cybersecurity guidances and standards have quite evolved the last few months.
It's time to push new templates!
Friday, 23 February 2024
By Mitch on Friday, 23 February 2024, 14:21 - Standards
IEC 81001-5-1 is now the standard for cybersecurity in medical devices. But is this standard asking too much for?
Friday, 6 October 2023
By Mitch on Friday, 6 October 2023, 14:09 - Regulations
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.
Monday, 20 February 2023
By Mitch on Monday, 20 February 2023, 13:56 - Standards
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?
