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Friday, 28 August 2015
By Mitch on Friday, 28 August 2015, 12:54 - Regulations
We continue this series on validation of software used in production and QMS with the Validation Protocol and Reports.
Friday, 24 July 2015
By Mitch on Friday, 24 July 2015, 11:57 - Regulations
We continue this series on validation of software used in production and QMS with the Validation Master Plan (VMP).
Better than endless explanations, I added a Validation Master Plan template to my templates repository page.
Friday, 20 March 2015
By Mitch on Friday, 20 March 2015, 17:03 - Regulations
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.
Friday, 21 November 2014
By Mitch on Friday, 21 November 2014, 12:46 - Regulations
At last! The FDA has published last October a guidance about cybersecurity that matters!
Not that the guidance previously published about Off-the-shelf software cybersecurity wasn’t worth reading it (Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software), but its scope was more than reduced.
Friday, 31 October 2014
By Mitch on Friday, 31 October 2014, 12:48 - Regulations
We continue this series about DHF, DMR and DHR, with the Device History Record.
Friday, 17 October 2014
By Mitch on Friday, 17 October 2014, 12:44 - Regulations
We continue this series about DHF, DMR and DHR, with the Device Master Record.
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:
Let's begin with the DHF.
Friday, 27 June 2014
By Mitch on Friday, 27 June 2014, 11:10 - Standards
Continuing with ISO/DIS 13485:2014, after having made an overview of software-related changes in the last article, let's focus on the new clause #4.1.6.
Monday, 26 May 2014
By Mitch on Monday, 26 May 2014, 00:02 - Misc
After MHRA's guidance on standalone software, we continue with another official document published by the International Medical Device Regulators Forum (IMDRF): the consultation on software as a medical device: Possible Framework for Risk Categorization and Corresponding Controls.
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, 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, 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.
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.
Is your App a medical device and does it need to be CE Marked or FDA cleared ?
Wednesday, 25 September 2013
By Mitch on Wednesday, 25 September 2013, 17:28 - Regulations
After two years of gestation, FDA issues final Guidance on Mobile Medical Apps!
Friday, 2 August 2013
By Mitch on Friday, 2 August 2013, 11:12 - Regulations
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!
Friday, 12 July 2013
By Mitch on Friday, 12 July 2013, 14:33 - Regulations
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?
Friday, 8 March 2013
By Mitch on Friday, 8 March 2013, 14:09 - Standards
We've seen in the two previous posts several solutions on how to treat legacy software according to IEC 62304.
But there is nothing equivalent to this discussion in IEC 62304. The standard is silent about these situations.
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