Software in Medical Devices, by MD101 Consulting

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Tag - CE Mark

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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

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, 22 February 2012

The essential list of guidances for software medical devices

Too many documents in too many places, that’s what I felt the first time I looked for guidances and other similar stuff about software medical devices.
Where do I find relevant documents?
Which one do I begin with?
My answer:
I created a page where I gather my own list of guidances. It’s a selection of guidances and recommendations for CE mark.

Click here to see the list.

Hope you enjoy it :-)

Monday, 6 February 2012

MEDDEV 2.1/6 Guidelines on classification of standalone software released!

New! MEDDEV 2.1/6 Guidelines on classification of standalone software released!
HIS, CIS, PDMS, RIS, PACS, LIMS … Which ones are medical devices, which ones are not?
To answer this question, the European Commission issued a new Guidelines document: MEDDEV 2.1/6, about the qualification and classification of standalone software as Medical Devices or In Vitro Diagnosis Devices.
Download here
After the draft guidance of the FDA about mobile apps, after the guide on regulation of health apps by a UK medical charity, this MEDEV is the third document released in a few months about standalone software.

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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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Friday, 4 November 2011

How to classify and CE mark software

Medical devices shall have CE mark before being sold in the EU. The process to have CE mark can be summarized this way:

  1. Determining the class of the device,
  2. Choosing the CE procedure to apply,
  3. Declaring CE conformity of the device.

Software follows exactly the same process as other devices. Here are the steps to follow to CE mark software.

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