Friday, 4 January 2013
By Mitch on Friday, 4 January 2013, 12:10 - Misc
The Internet of Things is probably the next step of the networking of our everyday life.
The web 1.0 was the era where websites were only read-only, with very little interaction.
The web 2.0 is the web of today, with social networks and heavy interaction between web users.
We don't know yet what the web 3.0 will be. But the interaction between networked objects and between networked people and networked objects is perhaps one facet of the web of the future.
Continue reading...
Friday, 28 December 2012
By Mitch on Friday, 28 December 2012, 13:47 - Misc
If you want to know how to have a 21 CFR Part 11 compliant system, have a look at Daniel Riganati's blog:
http://riganati.blogspot.fr/2012/06/validation-its-more-than-just-testing.html
It's damned well explained! Congrats Daniel!
Merci Beaucoup!
This blog is alive since september 2011. I began with very few readers (3 per day including my family :)
Now I have 100 unique visitors per day. You break through the threshold this month in december.
You all made me a nice present at the end of 2012!
I want to thank you all and wish you an happy new year.
Happy new year
Feliz Año nuevo
Bonne Année
Frohes neues Yahr
Friday, 21 December 2012
By Mitch on Friday, 21 December 2012, 12:59 - Misc
We all use Wifi in our everyday life. When we don't have it, we growl and yowl. When we have to use a good old RJ45 network cable, we feel like a dog on a leash.
Continue reading...
Friday, 14 December 2012
By Mitch on Friday, 14 December 2012, 12:35 - Processes
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.
Continue reading...
Friday, 7 December 2012
By Mitch on Friday, 7 December 2012, 12:45 - Processes
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
By Mitch on Friday, 30 November 2012, 12:06 - Processes
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.
Continue reading...
Friday, 23 November 2012
By Mitch on Friday, 23 November 2012, 13:06 - Regulations
The Global Harmonization Task Force released an update of their guidance on Essential Principles of Safety and Performance of Medical Devices. It supersedes the last version released in 2005.
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Friday, 16 November 2012
By Mitch on Friday, 16 November 2012, 12:34 - Processes
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.
Continue reading...
Friday, 9 November 2012
By Mitch on Friday, 9 November 2012, 14:06 - Misc
Endeavour Agile ALM is an Open-Source solution for Agile project and resource management.
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Friday, 2 November 2012
By Mitch on Friday, 2 November 2012, 14:11 - Processes
Following the article about software verification, let's see what software validation is.
Continue reading...
Friday, 26 October 2012
By Mitch on Friday, 26 October 2012, 14:09 - Processes
Many people make the confusion between verification and validation. There is no exception for software! I'd even say that the confusion is even worse for standalone software.
Let's see first the definition of verification and validation. I borrowed these definitions from the FDA website:
- Verification is confirming that design output meets the design input requirements,
- Validation is ensuring that the device conforms to defined user needs and intended uses.
OK, this remains theoretical. How to do that with software medical devices?
In this article I focus on verification and will focus on validation in the next article: What is software validation.
Continue reading...
Friday, 19 October 2012
By Mitch on Friday, 19 October 2012, 04:32 - Standards
Let's continue a former post about dealing with ISO 13485 in a software company. ISO 13485 and ISO 14971 are a bit like sister standards. You can't implement one without the other!
But how to deal with ISO 14971 in a software company, actually?
Continue reading...
Friday, 12 October 2012
By Mitch on Friday, 12 October 2012, 06:42 - Regulations
Continue reading...
Monday, 8 October 2012
By Mitch on Monday, 8 October 2012, 11:13 - Regulations
The proposal of new regulation for CE Mark of medical devices was unveiled last week. If you've not heard about it, you were in the desert without access to the internet.
I won't argue on the length of the document or the consequences of this possible new regulation on the early release of technologic improvements in the european market. I invite you to have a look at Mat's article.
What's new for software?
Let's see what's new for software in this proposal. To do so, I took my best PDF viewer and searched for "software" in the actual directive and in the new proposal.
Continue reading...
Friday, 28 September 2012
By Mitch on Friday, 28 September 2012, 12:10 - Misc
In two previous articles, I talked about the differences of bugs, software failures, and risks.
I left the discussion unfinished about the probability of occurence of a software failure or a defect.
I think that assessing the probability of occurence of a software failure is a hot subject. I've already seen many contradictory comments on this subject. It's also a hot subject for software manufacturers that are not well used to risk assessment.
Continue reading...
Friday, 21 September 2012
By Mitch on Friday, 21 September 2012, 13:08 - Misc
The scenarists of Warner Bros have unlimited imagination when they create a new series!
H+ Digital Series is the story about a computer implant that connect people to the internet 24 hours - 7 days. It's like the google glasses, with no glasses. The digital overlay is supposed to be sent direcly to the brain by cerebral waves or the like...
In their will of mimicking the reality, they've created a fake website of the company that designed the implant: Hplus Nano Teoranta and even user testimonials in the teasers of the series!
Wow! Will they have a fake booth at the world congress of neurology? :-)
Continue reading...
Friday, 14 September 2012
By Mitch on Friday, 14 September 2012, 12:06 - Misc
In my previous post about Bugs, Software Risks and Software Failures, I explained the concepts of bugs, defects or anomalies, and the concept of software failure.
Let's continue now with Risks.
Continue reading...
Friday, 7 September 2012
By Mitch on Friday, 7 September 2012, 18:10 - Misc
A bug can lead to a software failure.
Having bugs is a risk.
Having a software failure is a risk.
A software failure is not necessarily a bug!
Do you follow me?
If not, let me give you some more explanations.
Continue reading...
Friday, 31 August 2012
By Mitch on Friday, 31 August 2012, 16:47 - Processes
Safety critical software always face the big freeze before certification.
This happens because watefall model is the prefered software development cycle for safety critical software. Thus you can't change anything if you're in qualification phase for certification.
To be more flexible, some smart people created the concept of continuous certification. The purpose of continuous certification is to apply the principles of agile methods to safety critical software development.
Continue reading...
Friday, 24 August 2012
By Mitch on Friday, 24 August 2012, 01:13 - Misc
Hello,
I run this blog on a free platform, it is going to be full and I'll be soon unable to use it any more. I spent most of my time to port the blog on a new PAAS this week. I continue with the same blog engine (dotclear), to maintain the architecture and the URLs. It's very important to keep my google rank!
I should be able to release it in september, when all bugs are fixed.
One important thing happened this week: the ASEAN countries released a draft of ASEAN Medical Device Directive (AMDD), see here . This is a bit like the CE medical devices directive, with one set of regulations for many countries.
It gives me the opportunity to introduce the concept: Develop once, Certify anywhere
It means that, with the convergence of regulations, one set of documents is enough to create a technical file submitted in many countries. For example, data submitted to the EU authorities would be also submitted to the ASEAN member countries.
I'll post more details on this concept later on.
Bye.
Post edited August 29th 2012:
Here is the new blog platform!
No big changes for you, only a new layout.
I let it run for one week in beta test to see if everything's ok.
The previous blog is still active, for backup: EDIT previous blog platform link removed, blog closed.
This blog is registered on technorati with code: W4S4GJXCQPTP
