Software in Medical Devices, by MD101 Consulting

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Friday, 17 October 2025

Artificial Intelligence in Medical Devices - Part 4 Risk Management

We continue this series of articles on Artificial Intelligence with the Risk Management Process.
Simply put, risk management for MDAI isn't dramatically different from risk management for classical MDSW. Yet, some interesting points of view can be found in literature and standards. Namely AAMI TIR 34971 and FDA guidances on AI. The future ISO TS 24971-2 on risks with AI should be published in 2026.

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Friday, 29 August 2025

Artificial Intelligence in Medical Devices - Part 3 Data Management

We continue this series of articles on Artificial Intelligence with the Data Management Process.
This process is required by article 10 of the AI Act, but also from a MDR viewpoint to document the process feeding the AI design process (seen in the previous article part 2) with the right data.

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Friday, 1 August 2025

Artificial Intelligence in Medical Devices - Part 2 Design

After introducing this series in the previous post, we continue with MDAI design.

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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, 15 May 2020

Software release vs design transfer

A recurring question is the confusion, or more precisely the difference between software release of IEC 62304, and design transfer of ISO 13485.

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Saturday, 9 November 2019

Eudamed Software Development LifeCycle

This is the Eudamed Software Development LifeCycle.

Eudamed Software Development Lifecycle.png, Nov 2019


Welcome to the world of software engineering, Eudamed!

Friday, 6 July 2018

IEC 62366-1 and Usability engineering for software

Usability is a requirement, which has been present in regulations since a long time. It stems from the assessment of user error as a hazardous situation. It is supported by the publication AAMI HE75 standard, FDA guidances, and the publication of IEC 62366 in 2008 followed by IEC 62366-1:2015. Although usability engineering is a requirement for the design of medical devices, most of people designing software are not familiar with this process. This article is an application of the process described in IEC 62366-1 to software design.

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Friday, 1 July 2016

How to validate software development tools like Jira or Redmine?

Following the discussion on ISO/TR 80002-2 and AAMI TRI 36 in the previous article, here are some tips on how to validate workflow and data management software like Jira or Redmine.

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Friday, 19 June 2015

Validation of software used in production and QMS - Part 1 introduction

Validation of software is an unlimited source of topics!
After discussing in a previous article the validation of software in development process, let's see how to validate software used in production processes and in the management of QMS documents and records.

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Friday, 11 April 2014

Validation of compiler and IDE - Why, when and how to? - Part 3

Coming back to the discussion about validating compilers and IDE, here are a few more comments I have on this topic.

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Friday, 28 March 2014

Validation of compiler and IDE - Why, when and how to? - Part 2: compilers

We saw in the last post how to validate a software development tool. But we saw also that validating a compiler this way is not a satisfactory task.
Then: Why, when, and how to validate a compiler?

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Friday, 14 March 2014

Validation of compiler and IDE - Why, when and how to? - Part 1

Validating the compiler used in software development is a recurring issue. To what extent a compiler should be validated, when, how and why?
In the same vein, we can extend the question of validation to all tools used in the software development environment: integrated development environment, configuration management tools, compiler (and linker), automated test tools.

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Friday, 28 February 2014

Goto Fail

If you've haven't heard about Apple's security flaw registered as CVE-2014-1266 on apple website, you probably were on planet Mars.
Basically, it was unsafe to use https connections. I couldn't help but write an article about this!
Components dealing with secured connections are abolutely critical. Applying rigorous development process is the best chance to avoid any trouble with these components.

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Friday, 25 October 2013

Testing is overrated

Software testing is the keystone of bugs discovery. Most of software engineers and project managers think this assertion is true!

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Friday, 11 October 2013

How to validate a software medical device running on web browsers?

Your company develops medical web apps (HTML/JS, HTML5 or any other client-side technology) and your customers would like them to run on every web browser.

Web browsers are SOUP, according to IEC 62304. In case of Chrome and Firefox there are dozens of versions...

Does it mean that software has to be tested - and documented - with every single browser and every single version of the browser?
That's a nightmare!

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Friday, 14 December 2012

En route to Software Verification: one goal, many methods - part 3

In my last post, I explained the benefits of static analysis. This software verification method is mainly relevant to find bugs in mission critical software. But it fits the need of bug-free software for less critical software as well.
Static analysis can be seen as an achievement in the implementation of software verification methods. Yet, other methods exists that fit very specific purposes.

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Friday, 7 December 2012

En route to Software Verification: one goal, many methods - part 2

In my last article, I talked about the most classical methods used to verify software: human testing (driven by test cases or not) and unit tests. I was about to talk about static analysis, that I place at a higher level of complexity in the list of verification methods, but I have to say a bit more about unit tests.

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Friday, 30 November 2012

En route to Software Verification: one goal, many methods - part 1

Software verification is easy to define: to demonstrate that software works as it was specified (and without bugs!). But there's not a unique way to do it.
Let's see what methods we have in hands to verify software.

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Friday, 16 November 2012

V&V: verification & validation, doing it right.

Writing about V&V in two previous posts, I had a lot of comments from people on a well-known social network. They made corrections to my view of V&V and brought their own definitions.
Here is an excerpt of their comments.

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Friday, 2 November 2012

What is software validation?

Following the article about software verification, let's see what software validation is.

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