Software in Medical Devices, a blog by MD101 Consulting

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Monday 12 May 2014

MHRA guidance about standalone software

MHRA, the regulatory authority of the UK, published in march a guidance on medical device standalone software.
This guidance is a prime source of information about software in medical devices in the European Union. It gathers all existing information about the way medical device software is regulated in the EU.

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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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Friday 1 November 2013

Essential list of guidances updated

The last time I updated my essential list of guidances was in 2012. Today I've done a full refresh of that page with:

  • Change of GHTF to IMDRF,
  • Update of links to TEAM-NB website,
  • Update of FDA guidances, especially the brand new guidance about mobile medical applications.


I hope you'll find all relevant regulatory information about software on that essential list of guidances.

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 9 August 2013

FDA recognizes 25 standards about IT risk management, interoperability and cybersecurity

FDA recognizes 25 standards about risk management, interoperability and cybersecurity.
More on AAMI news website and the link to the Federal Register notice of Aug 6, 2013.

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!

Saturday 27 July 2013

IMDRF published a proposed document on standalone software definitions

At be beginning of june 2013, the International Medical Devices Regulators Forum (IMDRF) published a proposed document on standalone software definitions.
The goal of this document is to harmonize the key definitions related to standalone software.

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Friday 19 July 2013

Unique Device Identification for software medical device - part 2

This is the second part of our discussion about Unique Device Identification (UDI).

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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 21 June 2013

New FDA Cyber Security Draft Guidance

Interrupting our series about IEC 62304 SOUP, we have breaking news from the FDA!
The FDA published this month a new Draft Guidance about Cyber Security and released a Safety Communication about Cybersecurity for Medical Devices and HospitalNetworks .

The federal agency recommends that manufacturers review their cybersecurity practices and policies to assure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices. In other words, hacking treats, network intrusions, and the like, have to be addresses in the software risk assessment report.

Bouncing back to our series about SOUP, such risks shall be assessed when a SOUP is integrated in your software.

Friday 22 March 2013

EU Guidances - What's new?

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.

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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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Friday 1 February 2013

FDA Draft Guidance on medical devices for home use

Too busy to write a long post this week.

I've not talked about a new FDA draft guidance yet:
The Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use.

Though not specific to software, this guidance has consequences on software design of medical devices for home use. The design team has to watch for problems linked to the users, their diseases and their environment where things can get messy.

Most of the content of that guidance is not intended to be applied specifically to software. But it contains a few elements that are applicable to software, mainly alarms, human factors, and use of device in emergency. That is another way of saying that ergonomics and human factors engineering are important input data for software development.

Friday 23 November 2012

New GHTF essential principles: software validation added!

The Global Harmonization Task Force released an update of their guidance on Essential Principles of Safety and Performance of Medical Devices. It supersedes the last version released in 2005.

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Friday 12 October 2012

EU Proposal of new regulation: what's new for software? - part 2

Here is the second part of my last article about EU Proposal of new regulation.

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Monday 8 October 2012

EU Proposal of new regulation: what's new for software? - part 1

The proposal of new regulation for CE Mark of medical devices was unveiled last week. If you've not heard about it, you were in the desert without access to the internet.

I won't argue on the length of the document or the consequences of this possible new regulation on the early release of technologic improvements in the european market. I invite you to have a look at Mat's article.

What's new for software?

Let's see what's new for software in this proposal. To do so, I took my best PDF viewer and searched for "software" in the actual directive and in the new proposal.

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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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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 :-)

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