To content | To menu | To search
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.
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, 6 April 2012
By Mitch on Friday, 6 April 2012, 11:08 - Misc
This article is the last of three articles which deal with the concept of
"inflation" of medical devices. The first
one was on inflation of standards, the second
about inflation of regulations. This one, the most interesting to my eyes, is
about multiplication of apps on mobile devices, especially smartphones and
tablets.
More that 6000 apps are classified in the "heath", "heathcare" or "medical"
categories of the Apple or Android appstores. Many of these apps are classified
as medical devices and are in the scope of regulations like FDA and CE Mark.
Note that some apps may be regulated the FDA but not the CE Mark or
vice-versa.
Friday, 30 March 2012
By Mitch on Friday, 30 March 2012, 10:51 - Regulations
Today I’m going to talk about the inflation to regulations in the world of software for medical devices. In my previous post, I had a look at the inflation of standards for medical devices. As the medical devices industry is heavily controlled by regulations, they deserve a dedicated post.
Friday, 9 March 2012
By Mitch on Friday, 9 March 2012, 13:45 - Standards
Don't worry, I'm not going to talk about money and quantitative easing! I let people with better knowledge in economics (that makes a lot of people!) do that.
When I talk about inflation, I mean the inflation of software medical devices in their number and variety, which creates a collateral inflation in the number of regulations, guidances, standards, and the like.
This post is the first of a series of three. In this first post, I focus on the inflation of standards. The next one will be on the inflation of regulations and the last one on the inflation of medical devices.
Wednesday, 18 January 2012
By Mitch on Wednesday, 18 January 2012, 10:33 - Regulations
Breast implants are technically far from software and one may say they don’t have anything in common. Yes, they do, when software is part of a medical device, they are both subject to the regulation of the 93/42 CE directive.
Is it possible to have a massive injury of people with software, like the one we discovered with the breast implants scandal?
To understand how this happened, let us begin with a brief history of the CE mark.
Monday, 14 November 2011
By Mitch on Monday, 14 November 2011, 10:32 - Regulations
The boom of mobile apps on smart phones clearly impacts the medical devices industry. Doctors are eager to have the last software gadget (the app) on their hardware gadget (the smartphone, the tablet). As a result, many apps on Apple Store and Android Store fall into the scope of medical devices: terminal to remotely display medical images, apps to compute doses of medicines, an so on ... The list is long.
And gess what? These apps shall be certified before being put in the Apple-Android stores. The FDA is clear about these "mobile medical apps" in a draft guidance published in july 2011: "For the subset of mobile medical apps that are subject to regulatory oversight, manufacturers must meet the requirements associated with the applicable device classification." see the Draft Guidance. For the CE mark, the rule is the same, mobile medical apps fall into the category of active medical devices.
The big family of medical devices is getting more and more children. Welcome to the baby smartphone apps!
page 3 of 3 - next entries »
