Friday, 6 July 2018
By Mitch on Friday, 6 July 2018, 13:41 - Processes
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.
Friday, 8 April 2016
By Mitch on Friday, 8 April 2016, 14:25 - Standards
Continuing our series about IEC 82304-1, let's see the consequences of this standard on agile software development processes.
Tuesday, 3 December 2013
By Mitch on Tuesday, 3 December 2013, 09:41 - Standards
In the last article we've seen the consequences of regulations on Apps, which run on smartphone or - more broadly - on mobile platforms.
Today, let's have a look at the main standard to apply when developing software for medical devices: IEC 62304, and the context in which most people want to apply it: agile methods.
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, 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, 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.
Friday, 3 August 2012
By Mitch on Friday, 3 August 2012, 22:01 - Templates
All templates I have written are listed in my templates repository page. I already explained in that page and some other articles how to use them with waterfall development process.
But their use is not obvious with agile methods. Here are a few explanations.
Friday, 6 July 2012
By Mitch on Friday, 6 July 2012, 13:17 - Processes
Are agile methods compatible with the constraints of development set by IEC
62304 standard of class C software?
series of three posts about agile methods and risks analysis. I focus in
this post on IEC 62304 class C critical software.
Saturday, 23 June 2012
By Mitch on Saturday, 23 June 2012, 16:40 - Processes
We've seen in my last post that it's possible to have agile development methods combined with a risk management process. To be compliant with ISO 14971 standard, a risk management plan that describes this process along iterations, has to be written. And a risk assessment report has to be created in iteration 0 and updated in every iteration, by following the risk management process like the one found in figure 1 or figure B.1 of ISO 14971 standard.
Sunday, 17 June 2012
By Mitch on Sunday, 17 June 2012, 18:29 - Processes
This post is the continuation of the post of last week.
We've seen in that post that fixing bugs during software maintenance is like a small chunk of design, excepted that software specifications do not change. Therefore risk management process when fixing bugs is very close to risk management process during design, without the initial assessment of risks at the beginning of the software development cycle.
Saturday, 9 June 2012
By Mitch on Saturday, 9 June 2012, 16:45 - Processes
This post comes after a series of three posts where I exposed my thoughts about development of software medical devices with agile methods.
These posts were focussed on software development. Risk management deserves its own series of posts. Here is the first of three.
Saturday, 2 June 2012
By Mitch on Saturday, 2 June 2012, 09:45 - Processes
In my previous post, I explained how to adapt agile methods to IEC 62304. I finish this series of 3 posts with some advices about the organization of an iteration and the software development team.
Wednesday, 16 May 2012
By Mitch on Wednesday, 16 May 2012, 17:15 - Processes
In my previous post, I explained how I tweaked the waterfall model to obtain something close to agile methods. But still not agile, actually...
Saturday, 12 May 2012
By Mitch on Saturday, 12 May 2012, 20:55 - Processes
IEC 62304 is the standard to apply for software in medical devices. It is not bound to any software development method or model. Though not explicit, using the waterfall development model is the most straighforward way to apply this standard.
The waterfall model has become old fashioned to the eyes of most of software developers, with the emergence of agile methods. Agile methods are so popular now that everydody wonders how to apply IEC 62304 with agile methods.
An AAMI/CDV-1 TIR(SW1) - Guidance on the use of agile practices in the development of medical device software exists about this subject. But it is still a draft and only members of AAMI have access to it.
So, how to use agile methods and still be compliant with IEC 62304?
Here are my thoughts about these questionings!