Software in Medical Devices, a blog by MD101 Consulting

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Friday 31 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 5 Deployment

Back to my blog after a while (you missed me :-)). After the previous article about usability, we're going to see the deployment of mobile medical apps. This article is the last of this series on clearance of mobile medical applications, before conclusion.

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Friday 17 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 4 Usability

In the last article, we saw the concerns about the reliability of wireless connections and how to handle them.
Today, we are going to have a look at something quite important for mobile platforms: usability and humans factors engineering (HFE).

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Friday 3 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 3 Wireless

In the last article, we explained why agile methods are so popular for mobile app software development. Today, we are going to review a major characteristic of mobile platforms: wireless connection.

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Friday 15 November 2013

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 1 regulations

Today I begin a new series of articles about developing (or more broadly designing) a smartphone App that is a medical device.

The very first question is:

Is your App a medical device and does it need to be CE Marked or FDA cleared ?

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Wednesday 25 September 2013

FDA issues final Mobile Medical Apps Guidance

After two years of gestation, FDA issues final Guidance on Mobile Medical Apps!

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Friday 2 August 2013

FDA Mobile Medical App Guidances should be released by the end of the year

To continue the topic about FDA draft guidances related to software and information systems, the FDA put in its top list the release of the Guidance of Mobile Medical Apps.

Guidance of Mobile Medical Apps is in the "A-list" of FDA and should be released by the end of 2013.

In hot topics, we have also a warning letter sent by the FDA to Biosense Technologies. The mobile App named uChek Urine Analyzer and developed by Biosense Technologies, falls into the category of medical devices, says FDA. Biosense claims on its website that the App turns the smartphone into a medical lab.

With such claim, it's not surprising that the FDA wants Biosense to submit a 510k!

Friday 12 July 2013

Unique Device Identification for software medical device - part 1

Unique Device Identification (UDI) had been in the pipes of regulators for a few years, beginning with the US in 2007, and following (as usual) by the European Union a few years later in 2012.
In parallel, the International Medical Device Regulators Forum (IMDRF) issued in 2011 a guidance on UDI, with the honorable objective of harmonizing UDI's all over the world.
What is the impact of these regulations and guidances on medical device software?

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Friday 8 March 2013

How to bring legacy software into line with IEC 62304? - part 3

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.

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Friday 8 February 2013

AAMI TIR45 on the use of agile methods becomes new FDA recognized standard

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.

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Monday 21 January 2013

Class A, B and C. Is it possible to reduce the documentation of detailed design of software medical devices?

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.

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Friday 18 January 2013

Class A, B and C. When to do detailed design of software medical devices?

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.

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Friday 6 April 2012

Inflation of software medical devices - part 3

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.

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Friday 30 March 2012

Inflation of software medical devices - part 2

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.

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Friday 9 March 2012

Inflation of software medical devices - part 1

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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.

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Wednesday 18 January 2012

Breast implants scandal: does the CE Mark malfunction?

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.

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Monday 14 November 2011

iPhone and Android applications are mobile medical devices

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!

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