Tag - development process
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Friday 15 May 2020
By Mitch on Friday 15 May 2020, 14:00 - Processes
A recurring question is the confusion, or more precisely the difference between software release of IEC 62304, and design transfer of ISO 13485.
Monday 3 July 2017
By Mitch on Monday 3 July 2017, 14:06 - Regulations
We continue this series of posts on cybersecurity with some comments on impacts of cybersecurity on the software development documentation.
Friday 1 July 2016
By Mitch on Friday 1 July 2016, 13:22 - Processes
Following the discussion on ISO/TR 80002-2 and AAMI TRI 36 in the previous article, here are some tips on how to validate workflow and data management software like Jira or Redmine.
Friday 8 April 2016
By Mitch on Friday 8 April 2016, 14:25 - Standards
Continuing our series about IEC 82304-1, let's see the consequences of this standard on agile software development processes.
Friday 5 February 2016
By Mitch on Friday 5 February 2016, 13:45 - Regulations
Friday 18 December 2015
By Mitch on Friday 18 December 2015, 15:33 - Misc
The IMDRF published in October 2015 the guidance document titled "Software as a Medical Device (SaMD): Application of Quality Management System" in its final version.
Friday 3 October 2014
By Mitch on Friday 3 October 2014, 13:58 - Regulations
After a temporary absence, I'm back on the waves with a new series of articles to talk about the files required by the 21 CFR 820 regulations:
- DHF: Design History File,
- DMR: Device Master Record,
- DHR: Device History Record.
Let's begin with the DHF.
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.
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 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!
Friday 13 September 2013
By Mitch on Friday 13 September 2013, 13:22 - Templates
Here is an update of Software Test Plan, Software Test Description, and Software Test Report templates.
Friday 6 September 2013
By Mitch on Friday 6 September 2013, 13:21 - Templates
Here is an update of System Architecture Description template and Software Detailed Design template.
Friday 5 April 2013
By Mitch on Friday 5 April 2013, 16:50 - Standards
Manufacturers of medical devices often ask themselves the obvious question:
Is it mandatory to be compliant both with IEC 60601-1 and IEC 62304?
Similarly, manufacturers of in vitro diagnosis devices ask themselves:
Are my devices in the scope of IEC 62304?
Obviously, medical devices (MD) with electric or electronic components are in the scope of IEC 60601-1. And in-vitro diagnosis devices (IVD) with electric or electronic components are in the scope of IEC 61010-1.
Do MD and IVD that embed software, fall in the scope of IEC 62304?
This is not so obvious.
Friday 1 March 2013
By Mitch on Friday 1 March 2013, 14:31 - Standards
We've seen in the last post how to manage changes in legacy software. Let's see it from another point of view: the type of legacy software.
Friday 22 February 2013
By Mitch on Friday 22 February 2013, 14:09 - Standards
Most of medical devices manufacturers have legacy software that was not designed according to IEC 62304. The devices that embed legacy software were once verified and validated. These devices and their software work well and no major adverse event were raised by software issues.
But one day, the manufacturer decides that it's time to bring that legacy software into line with IEC 62304, to align the technical file of that software (or the contribution of software to technical file content) with up-to-date standard or regulatory requirements.
Friday 18 January 2013
By Mitch on Friday 18 January 2013, 15:45 - Standards
In my last post, I explained what criteria should be taken to define the level of details of software units in a software design. This activity is not mandatory for all levels of risk of software in medical devices, though, according to IEC 62304.