Friday 12 December 2014
By Mitch on Friday 12 December 2014, 21:42 - Regulations
When should a manufacturer report devices changes or QMS changes to notified bodies, according to the 93/42/CE directive?
There hasn't been clear criteria, until the Notified Bodies Operating Group (NBOG) published the Best Practice Guide 2014-3 : Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.
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:
- DHF: Design History File,
- DMR: Device Master Record,
- DHR: Device History Record.
Let's begin with the DHF.
Friday 22 August 2014
By Mitch on Friday 22 August 2014, 14:12 - Standards
Continuing with the schedule of the ISO TC 210 committee, let's see when the next versions of IEC 62304 and IEC 62366 will be released.
Friday 8 August 2014
By Mitch on Friday 8 August 2014, 14:03 - Standards
Thanks to elsmar cove website, we know that the publication of the next version of ISO 13485 is postponed to 2016.
Bye bye ISO 13485:2015,
Welcome ISO 13485:2016!
Sunday 3 August 2014
By Mitch on Sunday 3 August 2014, 23:55 - Misc
If you follow regularly this blog, you noticed that there was not much new the last three weeks.
I had other commitments and took my remaining time to do a bit of admin on this blog to make it clean and up-to-date.
I've also changed the theme!
If you like it or not, you're welcomed to add a comment below.
I use a simple and free filter to discard junk comments. There are too many remaining junk comments so all comments are moderated. Then I publish manually those that are from real humans!
If you leave a comment, you'll need a bit time until a publish it. I apologize for the delay.
Friday 11 July 2014
By Mitch on Friday 11 July 2014, 22:34 - Regulations
The FDA released on june 20th 2014 a new draft guidance about:
- Medical Devices Data Systems (MDDS) subject to 21 CFR 880.6310,
- Medical image storage devices subject to 21 CFR 892.2010, and
- Medical image communications devices subject to 21 CFR 892.2020.
Link to FDA MDDS draft guidance here
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.
Friday 13 June 2014
By Mitch on Friday 13 June 2014, 10:43 - Standards
ISO/DIS 13485:2014 is the draft of the next version of ISO 13485. The final version should be published in 2015.
This new version brings a lot of new requirements for management of software related to medical devices. Let's see what's inside this draft!
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.
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.