Software in Medical Devices

Tuesday 3 December 2013

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 2 IEC 62304 and agile methods

In the last article we've seen the consequences of regulations on Apps, which run on smartphone or - more broadly - on mobile platforms.
Today, let's have a look at the main standard to apply when developing software for medical devices: IEC 62304, and the context in which most people want to apply it: agile methods.

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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 8 November 2013

14th november 2013 - World Usability Day

If usability is something theoretical for you, I encourage you to have a look at the World Usability Day.

The official theme of this year is: Healthcare: Collaborating for Better Systems

Dozens of events will be hosted by enthusiastic volunteers! Browse events on World Usability Day website. There's probably an event happening close to you.

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.

Friday 25 October 2013

Testing is overrated

Software testing is the keystone of bugs discovery. Most of software engineers and project managers think this assertion is true!

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Friday 18 October 2013

Template: new Software Configuration Management Plan

A new Software Configuration Management Plan (SCMP) Template, more adapted to agile methods.

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Friday 11 October 2013

How to validate a software medical device running on web browsers?

Your company develops medical web apps (HTML/JS, HTML5 or any other client-side technology) and your customers would like them to run on every web browser.

Web browsers are SOUP, according to IEC 62304. In case of Chrome and Firefox there are dozens of versions...

Does it mean that software has to be tested - and documented - with every single browser and every single version of the browser?
That's a nightmare!

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Monday 7 October 2013

EN ISO 14971:2012 ... Seriously?

I wanted to write an article about ISO 14971, when one of my colleagues told me that there was already something about it.
Damn it! He was quicker than me!
Here is the article on The Medical Devices Regulatory Affairs Toolbox blog: EN ISO 14971:2012 ... Seriously?

Friday 4 October 2013

Template: Risk Matrix Calculator

Risk matrixes are a useful way to show graphically the ranges in which risks are acceptable, tolerable and unacceptable. Here is an excel sheet that automates the computation of ranges.

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Friday 27 September 2013

Want to post a medical App on Apple Store? Things get harder!

Apple now asking app developers to provide sources of medical information says web site.

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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 20 September 2013

Templates Risk Management Plan and Risk Analysis Report updated

Here is an update of Risk Management Plan and Risk Analysis Report templates.

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Wednesday 18 September 2013

'Tipping point' for mobile health apps, on BBC News

Here is a record of an interview on BBC News radio.

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Friday 13 September 2013

Templates STP - STD and STR updated

Here is an update of Software Test Plan, Software Test Description, and Software Test Report templates.

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Tuesday 10 September 2013

What is Digital Health?

Last week in stumbled upon a video made by Paul Sonnier, head of the Digital Health Group on Linkedin.

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Friday 6 September 2013

Templates SAD and SDD updated

Here is an update of System Architecture Description template and Software Detailed Design template.

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Friday 30 August 2013

Template SRS updated

Here is an update of Software Requirements Specifications template.

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Friday 16 August 2013

2013 Summer break

Summer break. See you at the end of the month with new templates and new articles about hot subjects like mobile apps or software risks management.

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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!

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