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Friday, 7 February 2025
By Mitch on Friday, 7 February 2025, 15:21 - Standards
BS EN IEC 62304 Ed2. Medical device software - Software life cycle processes is published for public comments on BSI website!
By Mitch on Friday, 7 February 2025, 13:53 - Regulations
The FDA published early January 2025, a long-awaited guidance about Artificial Intelligence Enabled device software functions. This guidance contains FDA's recommendations on how to document an AI-enabled device in marketing submissions.
Almost 70 pages long, this guidance is a monster!
Thursday, 6 February 2025
By Mitch on Thursday, 6 February 2025, 14:47 - Misc
For those who've followed this blog for a long time, nothing relevant has been published on artificial intelligence / Machine Learning yet. Just a few words on artificial intelligence appear in the essential list of guidances, to refer to existing FDA guidance.
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.
Wednesday, 30 October 2024
By Mitch on Wednesday, 30 October 2024, 11:21 - Templates
The templates present on this site deserve a refresh. We continue with the 2024 version of the Version Description and the User Guide.
Friday, 18 October 2024
By Mitch on Friday, 18 October 2024, 17:30 - Templates
The templates present on this site deserve a refresh. We continue with the 2024 version of the Software Test Plan, the Software Test Description, and the Software Test Report.
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.
Wednesday, 18 September 2024
By Mitch on Wednesday, 18 September 2024, 21:57 - Templates
The templates present on this site deserve a refresh. We continue with the 2024 version of the Software Requirement Specification, the Software System Architecture Description, and the Software Design Specification.
Tuesday, 3 September 2024
By Mitch on Tuesday, 3 September 2024, 20:27 - Templates
The templates present on this site deserve a refresh. Here are the 2024 version of the Project Management Plan and the Software Development Plan
Friday, 26 July 2024
By Mitch on Friday, 26 July 2024, 13:12 - Regulations
And this is the Australian TGA who demonstrates that.
Friday, 19 April 2024
By Mitch on Friday, 19 April 2024, 13:32 - Regulations
Yes, 2025.
Why? Because Windows 10 end-of-support is the 5th October 2025.
Are there any MDD SaMD running on Windows 11? No, Windows 11 was released the 5th October 2021, just after May 2021.
So, all MDD SaMD are officially running on Windows 10. Till the 5th October 2025.
Thank-you Microsoft, you set a regulatory deadline involuntarily!
Friday, 29 March 2024
By Mitch on Friday, 29 March 2024, 13:42 - Regulations
The IMDFR organization published in January 2024 a new document on Medical Device Software: Considerations for Device and Risk Characterization
Say briefly, this document is a gem!
Friday, 15 March 2024
By Mitch on Friday, 15 March 2024, 14:35
Do you know that standard also have design specifications? This is the case for IEC 62304 2nd Edition.
This version doesn't exist yet. But its design specs have been defined and published on IEC website.
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, 20 October 2023
By Mitch on Friday, 20 October 2023, 14:12 - Regulations
The FDA released in August 2023 a new version of their guidance on off-the-shelf software (OTSS) use in medical devices. It’s worth noting that this guidance didn’t go through a draft version.
Something visible in the content of that guidance.
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.
Thursday, 28 September 2023
By Mitch on Thursday, 28 September 2023, 18:02 - Misc
Will it take more time than the age of the universe?
Friday, 8 September 2023
By Mitch on Friday, 8 September 2023, 14:30 - Standards
A new standard on security risk management for medical devices was published early 2023: AAMI SW96. Unlike AAMI TIR57 and TIR97, this is a standard, not a technical report.
Friday, 16 June 2023
By Mitch on Friday, 16 June 2023, 13:54 - Regulations
The final version of the FDA guidance on Content of Premarket Submissions for Device Software Functions has been published.
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