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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.
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?
Monday, 9 January 2023
By Mitch on Monday, 9 January 2023, 15:31 - Regulations
The FDA added late December 2022 IEC 81001-5-1 to the list of recognized consensus standards.
That's it. After beating around the bush on this blog on whether UL 2900-x or IEC 81001-5-1 would be applicable to 510(k) submissions and other regulatory clearances, we now have the answer.
We can use IEC 81001-5-1 as:
A good way to make thing (a bit) more simple.
Remark: UL 2900-x can still be applied in the US!
Friday, 6 January 2023
By Mitch on Friday, 6 January 2023, 13:24 - Regulations
The latest version of the FDA Guidance on Clinical Decision Support Software (CDSS) was published in September 2022. Here is a review of the document and a short comparison with the status of CDS with regard to the MDR.
Friday, 16 December 2022
By Mitch on Friday, 16 December 2022, 13:50 - Regulations
The Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022 has been published yesterday.
Monday, 5 December 2022
By Mitch on Monday, 5 December 2022, 11:47 - Misc
Hi EPSCO!
I hope you’re doing well!
We’re a bit concerned by your mindset, it looks like you don’t know where you have to go at your meeting of the 9th December.
Please find below some suggestions just for you.
Friday, 11 November 2022
By Mitch on Friday, 11 November 2022, 13:24 - Processes
That's a bit like a new album of your favorite group. You've been waiting it for years. At last, it's been released! Are you going to be be impressed or disappointed?
The draft FDA guidance on Computer Software Assurance [CSA] for Production and Quality System Software has been published in September 2022. At last!
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