AAMI SW96 2023 - The keystone of security risk management for medical devices
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.Before AAMI SW96If we start...
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Time it takes an evaluator to review your tech file in 2023
Will it take more time than the age of the universe?
View ArticleFinal 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.The draft had...
View ArticleNew version of the FDA guidance on off-the-shelf software use in medical devices
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....
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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?Impact of the standardIEC 81001-5-1 requires to unroll a full set of cyber activities...
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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!I updated the two templates for security risk management process: the Security Risk...
View ArticleIs my software in class A, B, C - IEC 62304 2nd edition
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...
View ArticleNew IMDRF document on Medical Device Software
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!The scope of this...
View ArticleTransition or not, your MDD SaMD may die in 2025, not 2028
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...
View ArticleOnce again MDR and rule 11 are proven to be wrong
An this is the Australian TGA who demonstrates that.We had a preview of this in a previous article in 2021, TGA repeats it in the Regulatory changes for software based medical devices - Version 1.3,...
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2024 templates - PMP and SDP
The templates present on this site deserve a refresh. Here are the 2024 version of the Project Management Plan and the Software Development PlanHere are the links to the templates:2024 Project...
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2024 templates - SRS, SAD and SDS
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...
View ArticleIEC 81001-5-2: AAMI SW96 cousin and IEC 80001-5-1 sister
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...
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2024 templates - STP, STD, and STR
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.Here are the links to the...
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2024 templates - Version Description and User Guide
The templates present on this site deserve a refresh. We continue with the 2024 version of the Version Description and the User Guide.Here are the links to these templates:2024 Version Description...
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2024 templates - Software Configuration Management Plan and Usability...
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.Here are the links to these...
View Article2025 on artificial intelligence
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...
View ArticleFDA Guidance on Artificial Intelligence enabled device software functions
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...
View ArticleIEC 62304 2nd Edition draft ready for public comments
BS EN IEC 62304 Ed2. Medical device software - Software life cycle processes is published for public comments on BSI website!This new draft version of the standard is really an improvement, compared to...
View ArticleTeam-NB questionnaire on artificial intelligence in medical devices
The team-NB published a questionnaire on artificial intelligence in medical devices in November 2024. This questionnaire is simply a (very long) list of questions that a Notified Body may take one by...
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