Monday 12 May 2014
By Mitch on Monday 12 May 2014, 07:40 - Regulations
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.
Friday 25 April 2014
By Mitch on Friday 25 April 2014, 13:26 - Templates
Here is a new template: the Software Development Tool Validation Plan.
It is made for validation of software development tools, as seen in the previous series of posts.
It is very similar to the all-in-one template but with a major difference: it contains sections and comments to help validating software not internally developed, like software bought to a vendor or open-source software.
It doesn't contain the risk management data. They shall remain in the dedicated templates: Risk management plan and Risk analysis report.
More templates on my templates repository page.
Please, feel free to give me feedback on my e-mail firstname.lastname@example.org
I share this template with the conditions of CC-BY-NC-ND license.
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 France License
Friday 11 April 2014
By Mitch on Friday 11 April 2014, 13:27 - Processes
Coming back to the discussion about validating compilers and IDE, here are a few more comments I have on this topic.
Friday 28 March 2014
By Mitch on Friday 28 March 2014, 12:50 - Processes
We saw in the last post how to validate a software development tool. But we saw also that validating a compiler this way is not a satisfactory task.
Then: Why, when, and how to validate a compiler?
Friday 14 March 2014
By Mitch on Friday 14 March 2014, 13:26 - Processes
Validating the compiler used in software development is a recurring issue. To what extent a compiler should be validated, when, how and why?
In the same vein, we can extend the question of validation to all tools used in the software development environment: integrated development environment, configuration management tools, compiler (and linker), automated test tools.
Friday 28 February 2014
By Mitch on Friday 28 February 2014, 13:49 - Processes
If you've haven't heard about Apple's security flaw registered as CVE-2014-1266 on apple website, you probably were on planet Mars.
Basically, it was unsafe to use https connections. I couldn't help but write an article about this!
Components dealing with secured connections are abolutely critical. Applying rigorous development process is the best chance to avoid any trouble with these components.
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 31 January 2014
By Mitch on Friday 31 January 2014, 12:43 - Misc
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.
Friday 17 January 2014
By Mitch on Friday 17 January 2014, 12:36 - Regulations
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).
Friday 3 January 2014
By Mitch on Friday 3 January 2014, 12:34 - Regulations
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.
Saturday 28 December 2013
By Mitch on Saturday 28 December 2013, 13:38 - Misc
2013 was the year of the confirmation of your interest in my blog. You were 100+ unique visitors per day. A success for a so specific subject!
I thank all of you, who supported my blog by reading the posts and downloading the templates.
Tuesday 3 December 2013
By Mitch on Tuesday 3 December 2013, 09:41 - Standards
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.
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.
The very first question is:
Is your App a medical device and does it need to be CE Marked or FDA cleared ?
Friday 8 November 2013
By Mitch on Friday 8 November 2013, 20:36 - Misc
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
By Mitch on Friday 1 November 2013, 09:48 - Regulations
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
By Mitch on Friday 25 October 2013, 19:05 - Processes
Software testing is the keystone of bugs discovery. Most of software engineers and project managers think this assertion is true!
Friday 18 October 2013
By Mitch on Friday 18 October 2013, 13:38 - Templates
A new Software Configuration Management Plan (SCMP) Template, more adapted to agile methods.
Friday 11 October 2013
By Mitch on Friday 11 October 2013, 14:08 - Processes
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!
Monday 7 October 2013
By Mitch on Monday 7 October 2013, 13:31 - Standards
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
By Mitch on Friday 4 October 2013, 13:24 - Templates
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.