Software in Medical Devices, by MD101 Consulting

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Friday, 19 April 2024

Transition 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 MDD SaMD are officially running on Windows 10. Till the 5th October 2025.
Thank-you Microsoft, you set a regulatory deadline involuntarily!

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Friday, 29 March 2024

New 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!

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Friday, 15 March 2024

Is 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 website.

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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!

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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?

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Friday, 20 October 2023

New 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.
Something visible in the content of that guidance.

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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.

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Thursday, 28 September 2023

Time it takes an evaluator to review your tech file in 2023

Will it take more time than the age of the universe?

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Friday, 8 September 2023

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.

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Friday, 16 June 2023

Final FDA guidance on Content of Premarket Submissions for Device Software Functions

The final version of the FDA guidance on Content of Premarket Submissions for Device Software Functions has been published.

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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?

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Monday, 9 January 2023

IEC 81001-5-1 was added to the list of recognized consensus standards

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

FDA Guidance on Clinical Decision Support Software

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.

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Friday, 16 December 2022

Manual on Borderline Classification Version 2 - December 2022

The Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022 has been published yesterday.

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Monday, 5 December 2022

Letter to EPSCO for their meeting of the 9th December 2022


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.

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Friday, 11 November 2022

Computer Software Assurance for Production and Quality System Software

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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Friday, 30 September 2022

NIS2 Directive: are you involved or concerned?

That’s the story of the pig and the hen for breakfast: the pig is involved (ham) and the hen is concerned (eggs). With the NIS2 directive in preparation, a medical device manufacturer will be in either situation.

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Friday, 2 September 2022

MDCG 2022-14: Red Queen Effect

The MDCG published in August 2022 the MDCG 2022-14 position paper on Notified body capacity and availability of medical devices and IVDs.

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Friday, 8 July 2022

IEC/TR 60601-4-5 kicked out of harmonized standards

The 6th June 2022, a draft request has been published to update the list of EU MDR/IVDR harmonized standards. This request brings changes to the list presented in the draft list of April 2021.

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Monday, 27 June 2022

MDR: Les Shadoks and MHRA: The Gibis

The UK Government response to consultation on the future regulation of medical devices in the United Kingdom has been published on Sunday 26th June 2022.

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