Software in Medical Devices, by MD101 Consulting

Continuing our series about IEC 82304-1, let's see the consequences of this standard on agile software development processes.

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.

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.

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.

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.

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.

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!