We continue this series about DHF, DMR and DHR, with the Device Master Record.
Friday, 17 October 2014
Content of DHF, DMR and DHR for medical device software - Part 2 DMR
By Mitch on Friday, 17 October 2014, 12:44 - Regulations
Friday, 3 October 2014
Content of DHF, DMR and DHR for medical device software - Part 1 DHF
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
When the next versions of IEC 62304 and IEC 62366 will be released?
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
Next version of ISO 13485 postponed to 2016
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
New theme
By Mitch on Sunday, 3 August 2014, 23:55 - Misc
Hello!
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.
Note:
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
New FDA Draft Guidance on MDDS
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The FDA released on june 20th 2014 a new draft guidance about: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Link to FDA MDDS draft guidance: EDIT - draft guidance superseded by final guidance, see this post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
ISO/DIS 13485:2014 strengthens requirements about software - Part 2
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
ISO/DIS 13485:2014 strengthens requirements about software - Part 1
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
IMDRF consultation: Software as a Medical Device
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
MHRA guidance about standalone software
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
Template repository updated: Software Development Tool Validation Plan
By Mitch on Friday, 25 April 2014, 13:26 - Templates
Template!
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 contact@cm-dm.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
Validation of compiler and IDE - Why, when and how to? - Part 3
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
Validation of compiler and IDE - Why, when and how to? - Part 2: compilers
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
Validation of compiler and IDE - Why, when and how to? - Part 1
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
Goto Fail
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
How to develop a smartphone App to be FDA-cleared or CE Marked? - part 6 Conclusion
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
How to develop a smartphone App to be FDA-cleared or CE Marked? - part 5 Deployment
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
How to develop a smartphone App to be FDA-cleared or CE Marked? - part 4 Usability
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
How to develop a smartphone App to be FDA-cleared or CE Marked? - part 3 Wireless
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
Happy new year 2014
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.
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