Software in Medical Devices, a blog by MD101 Consulting

To content | To menu | To search

Tag - mobile medical app

Entries feed - Comments feed

Friday 20 March 2015

When the FDA releases guidances in burst mode

If you watch from time to time the new guidances released by the FDA, you probably noticed that two guidances about software were released in january and february 2015.

Continue reading...

Friday 14 February 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 6 Conclusion

To conclude this series about clearance of mobile medical apps, here are a few tips to newcomers in the world in medical devices.

Continue reading...

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.

Continue reading...

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).

Continue reading...

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.

Continue reading...

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.

Continue reading...

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 ?

Continue reading...

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!

Continue reading...

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 imedicalapps.com web site.

Continue reading...

Wednesday 25 September 2013

FDA issues final Mobile Medical Apps Guidance

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

Continue reading...

Thursday 5 January 2012

Pfizer recalls Rheumatology Calculator smartphone App

Dozens of companies recall their medical devices every month. A recall happens when something wrong happened with the device, like a bad labeling or a bad sterilization. It's the responsibility of the manufacturer to warn ALL their customers and the government agencies that a given lot or batch of products has a defect. The batches shall be destroyed or sent back to the manufacturer for further analysis.
That's what happened to Pfizer with its Rheumatology Calculator, a smartphone app used to compute a score to assess the desease of patients according to complex algorithms. There is a bug in the app and it gives wrong results.

Continue reading...