Friday, 26 October 2012
By Mitch on Friday, 26 October 2012, 14:09
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.
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Friday, 31 August 2012
By Mitch on Friday, 31 August 2012, 16:47
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.
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Friday, 6 July 2012
By Mitch on Friday, 6 July 2012, 13:17
Are agile methods compatible with the constraints of development set by IEC
62304 standard of class C software?
After a
series of three posts about agile methods and risks analysis. I focus in
this post on IEC 62304 class C critical software.
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Saturday, 23 June 2012
By Mitch on Saturday, 23 June 2012, 16:40
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.
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Sunday, 17 June 2012
By Mitch on Sunday, 17 June 2012, 18:29
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.
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Saturday, 9 June 2012
By Mitch on Saturday, 9 June 2012, 16:45
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.
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Saturday, 2 June 2012
By Mitch on Saturday, 2 June 2012, 09:45
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.
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Wednesday, 16 May 2012
By Mitch on Wednesday, 16 May 2012, 17:15
In my previous post, I explained how I tweaked the waterfall model to obtain something close to agile methods. But still not agile, actually...
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Saturday, 12 May 2012
By Mitch on Saturday, 12 May 2012, 20:55
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!
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Wednesday, 4 January 2012
By Mitch on Wednesday, 4 January 2012, 12:09
Congratulations! You have signed a contract with a medical devices manufacturer. They don't have a very good knowledge of software. They rely on you to develop something brand new on a smartphone. The application they want to develop will bring new functionalities to doctors and let them do their jobs faster. Your customer chose you because you are the specialist of software on every OS’es on smartphones. You ensured him that your company can be in conformity with IEC 62304 standard. To that purpose, you modified and added the necessary procedures and forms to your quality system.
You have one year to develop the application, which fits their desires … and the medical devices standards!
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Monday, 12 December 2011
By Mitch on Monday, 12 December 2011, 11:36
Case example
You are a medical device company and you want to replace your old products by “smart” ones. Your competitors are doing it and you customers want them. “Smart” means something like an tiny computer (its amazing how small they are), with an operating system and big software. For electronic stuff, you have your own engineers or you have your subcontractors, which you have been working for 20 years with. They knew how to design embedded software on microchips. But they don’t know how to design software of higher level, with intelligent behaviour and complex algorithms.
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