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Friday, 8 February 2013
By Mitch on Friday, 8 February 2013, 14:41 - Regulations
The AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software enters in the list of recognized standards by the FDA. See here on Federal Register website.
Friday, 1 February 2013
By Mitch on Friday, 1 February 2013, 14:02 - Regulations
Too busy to write a long post this week.
I've not talked about a new FDA draft guidance yet:
The Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use.
Though not specific to software, this guidance has consequences on software design of medical devices for home use. The design team has to watch for problems linked to the users, their diseases and their environment where things can get messy.
Most of the content of that guidance is not intended to be applied specifically to software. But it contains a few elements that are applicable to software, mainly alarms, human factors, and use of device in emergency. That is another way of saying that ergonomics and human factors engineering are important input data for software development.
Monday, 21 January 2013
By Mitch on Monday, 21 January 2013, 15:34 - Standards
In the last two posts, we've seen what a software unit is, and when to do software detailed design, according to IEC 62304 and FDA Guidances.
Friday, 18 January 2013
By Mitch on Friday, 18 January 2013, 15:45 - Standards
In my last post, I explained what criteria should be taken to define the level of details of software units in a software design. This activity is not mandatory for all levels of risk of software in medical devices, though, according to IEC 62304.
Friday, 11 January 2013
By Mitch on Friday, 11 January 2013, 14:08 - Standards
IEC 62304 requires to split architecture of class C (mission critical) software into software items and software units. Software units are software items that can't be split into sub-items, according to the standard. Okay. But how to decide that an item can't be split into sub-items, and is a unit?
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.
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!
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.
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.
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.
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.
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.
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.
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.
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.
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:
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.
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?
Friday, 12 October 2012
By Mitch on Friday, 12 October 2012, 06:42 - Regulations
Here is the second part of my last article about EU Proposal of new regulation.
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.
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.
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.
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