Wednesday 4 March 2015
By Mitch on Wednesday 4 March 2015, 16:17 - Standards
The DIS2 (2nd draft version) of the next ISO 13485 was released in february.
It is published for comments on BSI draft review system website. Go to this website and search for 13485 to have a look at this draft.
Friday 30 January 2015
By Mitch on Friday 30 January 2015, 16:44 - Standards
To continue with the last article about FDIS IEC 62366-1 standard, let's see now the consequences of this standard on software design.
Friday 9 January 2015
By Mitch on Friday 9 January 2015, 14:16 - Standards
The FDIS (final draft version) of IEC 62366-1 was released in November 2014. This version, also known as IEC 62366 2nd edition, is on the right track to be officially released in Q1 2015. It will supersede the IEC 62366:2007 + Amendment 1:2014.
By Mitch on Friday 9 January 2015, 14:00 - Misc
Happy New Year 2015!!!
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.
EDIT: elsmar cove forums is dead, see RIP elsmar cove.
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: EDIT - draft guidance superseded by final guidance, see this post
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 email@example.com
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?