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Friday, 8 March 2013
By Mitch on Friday, 8 March 2013, 14:09 - Standards
We've seen in the two previous posts several solutions on how to treat legacy software according to IEC 62304.
But there is nothing equivalent to this discussion in IEC 62304. The standard is silent about these situations.
Friday, 1 March 2013
By Mitch on Friday, 1 March 2013, 14:31 - Standards
We've seen in the last post how to manage changes in legacy software. Let's see it from another point of view: the type of legacy software.
Friday, 22 February 2013
By Mitch on Friday, 22 February 2013, 14:09 - Standards
Most of medical devices manufacturers have legacy software that was not designed according to IEC 62304. The devices that embed legacy software were once verified and validated. These devices and their software work well and no major adverse event were raised by software issues.
But one day, the manufacturer decides that it's time to bring that legacy software into line with IEC 62304, to align the technical file of that software (or the contribution of software to technical file content) with up-to-date standard or regulatory requirements.
Friday, 15 February 2013
By Mitch on Friday, 15 February 2013, 14:00 - Misc
Innovations in the field of medical devices are highly influenced by technologies like nano-sensors, bio-MEMS, and mobile platforms.
In this kind of devices, wearable sensors are emerging as the next must-have. Wearable sensors are tiny gadgets that you have permanently with you, hidden in your clothes or in a piece of jewelry. They monitor vital (or non-vital) signs like arterial pulse and transmit data to local computers or remote platforms. Data are analyzed on the receiver to control anything you want: high blood pressure...
Early adopters of such devices will surely be geeks or techno-victims, but we can bet in a few years everybody will have at least one.
A good example is the Shine by Misfits Wearables. It's a concentrate of technology that monitors body parameters and communicates with your smartphone. And it's a deliberately nice object!
For me it's also a concentrate of all buzzwords heard in innovative medical devices!
We don't know yet wether such objects will become truly useful medical devices or will remain gadgets. Wether they will change or not our habits, like smartphones did. That's the role of the market (doctors and the public) to say so.
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.
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