Software in Medical Devices

Friday 11 July 2014

New FDA Draft Guidance on MDDS

The FDA released on june 20th 2014 a new draft guidance about: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Link to FDA MDDS draft guidance here

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Friday 27 June 2014

ISO/DIS 13485:2014 strengthens requirements about software - Part 2

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.

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Friday 13 June 2014

ISO/DIS 13485:2014 strengthens requirements about software - Part 1

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!

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Monday 26 May 2014

IMDRF consultation: Software as a Medical Device

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.

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Monday 12 May 2014

MHRA guidance about standalone software

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.

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Friday 25 April 2014

Template repository updated: Software Development Tool Validation Plan

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.



Creative Commons 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

Coming back to the discussion about validating compilers and IDE, here are a few more comments I have on this topic.

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Friday 28 March 2014

Validation of compiler and IDE - Why, when and how to? - Part 2: compilers

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?

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Friday 14 March 2014

Validation of compiler and IDE - Why, when and how to? - Part 1

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.

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Friday 28 February 2014

Goto Fail

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.

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Friday 14 February 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 6 Conclusion

To conclude this series about clearance of mobile medical apps, here are a few tips to newcomers in the world in medical devices.

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Friday 31 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 5 Deployment

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.

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Friday 17 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 4 Usability

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).

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Friday 3 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 3 Wireless

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.

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Saturday 28 December 2013

Happy new year 2014

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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Tuesday 3 December 2013

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 2 IEC 62304 and agile methods

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.

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Friday 15 November 2013

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 1 regulations

Today I begin a new series of articles about developing (or more broadly designing) a smartphone App that is a medical device.

The very first question is:

Is your App a medical device and does it need to be CE Marked or FDA cleared ?

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Friday 8 November 2013

14th november 2013 - World Usability Day

If usability is something theoretical for you, I encourage you to have a look at the World Usability Day.

The official theme of this year is: Healthcare: Collaborating for Better Systems

Dozens of events will be hosted by enthusiastic volunteers! Browse events on World Usability Day website. There's probably an event happening close to you.

Friday 1 November 2013

Essential list of guidances updated

The last time I updated my essential list of guidances was in 2012. Today I've done a full refresh of that page with:

  • Change of GHTF to IMDRF,
  • Update of links to TEAM-NB website,
  • Update of FDA guidances, especially the brand new guidance about mobile medical applications.


I hope you'll find all relevant regulatory information about software on that essential list of guidances.

Friday 25 October 2013

Testing is overrated

Software testing is the keystone of bugs discovery. Most of software engineers and project managers think this assertion is true!

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