Software in Medical Devices, by MD101 Consulting

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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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Tuesday, 14 June 2022

MDCG 2022-11 - Monty Python and the Holy Grail

Have you seen the MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements?

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Friday, 10 June 2022

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission

The FDA issued in April a new draft guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance will supersede the guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices of 2014, when it is finalized. There’s no word about the draft guidance of 2018. We can suppose that one is obsolete.

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Monday, 23 May 2022

The MDR is born bad

The Medical Device Regulation (MDR) is born bad. The success of a project depends on its timing. It is clear that the MDR has been plagued by a series of setbacks that have hindered its implementation.

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Friday, 13 May 2022

Software as a Medical Device Post-Market Surveillance

Post-Market Surveillance (PMS) is one of the strengthened requirements of the Medical Device Regulation (MDR). Performing an effective PMS can be a time consuming task, shared by several departments of MD manufacturers. This is also true for SaMD.

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Friday, 22 April 2022

New SaMD Classification scheme

A new unofficial SaMD classification scheme. Will it be adopted with the postponement of the MDR?

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Friday, 15 April 2022

SaMD decommissioning, recall, removal and withdrawal

We saw in the previous post how the lifetime of a SaMD can be defined. Let's continue with the operations that can affect this lifetime.

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Friday, 25 February 2022

Medical Device lifetime and SaMD

Medical device regulations require the manufacturers to define lifetime for their devices. In the case of SaMD, this requirement needs some interpretation.

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