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Friday, 24 July 2015
By Mitch on Friday, 24 July 2015, 11:57 - Regulations
We continue this series on validation of software used in production and QMS with the Validation Master Plan (VMP).
Better than endless explanations, I added a Validation Master Plan template to my templates repository page.
Friday, 12 December 2014
By Mitch on Friday, 12 December 2014, 21:42 - Regulations
When should a manufacturer report devices changes or QMS changes to notified bodies, according to the 93/42/CE directive?
There hasn't been clear criteria, until the Notified Bodies Operating Group (NBOG) published the Best Practice Guide 2014-3 : Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.
Friday, 14 February 2014
By Mitch on Friday, 14 February 2014, 12:48 - Misc
To conclude this series about clearance of mobile medical apps, here are a few tips to newcomers in the world in medical devices.
Friday, 15 November 2013
By Mitch on Friday, 15 November 2013, 13:51 - Regulations
Today I begin a new series of articles about developing (or more broadly designing) a smartphone App that is a medical device.
Is your App a medical device and does it need to be CE Marked or FDA cleared ?
Friday, 22 March 2013
By Mitch on Friday, 22 March 2013, 11:59 - Regulations
A few words about guidances in Europe. News are rare enough to point them out.
First, the guidance on electronic labelling came into force on 1st march 2013, see the MHRA website for some explanations and the original decision on the EU website.
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, 22 February 2012
By Mitch on Wednesday, 22 February 2012, 09:21 - Regulations
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.
Hope you enjoy it :-)
Monday, 6 February 2012
By Mitch on Monday, 6 February 2012, 18:14 - Regulations
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.
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.
Friday, 4 November 2011
By Mitch on Friday, 4 November 2011, 14:20 - Regulations
Medical devices shall have CE mark before being sold in the EU. The process to have CE mark can be summarized this way:
Software follows exactly the same process as other devices. Here are the steps to follow to CE mark software.
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