Comments for Bob on Medical Device Software

Comment on Validation of Off-The-Shelf Software Development Tools by SL

SL — Tue, 31 Jan 2012 14:44:21 +0000

Hi all,

first of all thanks for the interesting post BOB.

@Karl:
Maybe GAMP5 (even if it comes from pharma) can give you a hint: GAMP knows 5 software categories. OSs fall into category 1 (infrastructure software) which is considered far from harming the patient.

moving along this line you should declare exactly which version/configuration of windows you are using and checking this as a kind of incoming goods inspection. (you verify that you bought the right windows version)

then you could check if windows was installed in the right way. (i guess errors during the installation would mean that you didn’t)

finally windows is widely used so you could state that errors in the system would at somepoint get recognized by the community and by checking for updates (at least updates that affect your intended use) you can get those errors repaired.

one other thing to consider are realtime requirements. if you have the need for a realtime OSS i guess this would be a critical point for validation.

i excuse for my bad english (as i’m no native speaker) and am looking forward to hear if anybody thinks along the same line.

greetings from austria

as an addition: for all of you out there looking for validiation of software that is not itself a medical product but automates processes: consider having a look at the AAMI-TIR 36.

Comment on Cloud Computing Design Patterns by Swipe webpage

Swipe webpage — Sun, 22 Jan 2012 23:07:37 +0000

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Comment on Validation of Off-The-Shelf Software Development Tools by Karl

Karl — Mon, 16 Jan 2012 15:45:21 +0000

Hi Bob,
I work for a company developing medical devices using application software to manage a robot. The application software runs on a regulat windows operating system and is programmed in .NET (thus using the .NET framework).

As I understand 62304, both the .NET framework and the windows operating system are SOUPs and needs to be treated as such. But how on earth am I supposed to verify/validate Windows? It would been an exhaustive task that would take a million years!

I have searched wide and far (i.e. googled) trying to find anyone who has actually done this but the only results I find are about OS in implants and other really HW close firmware OSs. Noone ever mentions application development in a windows environment.

What is your experience on this? Have you ever heard about anyone that successfully treated Windows as a SOUP?

Thanks for a great blog
Karl

Comment on Developing a real-time data flow and control model with WCF by Shweta

Shweta — Sat, 07 Jan 2012 11:28:59 +0000

Hi I am working on the similar kind of application. can i get a copy of your code?

Comment on Is the Zeo “Personal Sleep Coach” a Scam? by skippy

skippy — Fri, 06 Jan 2012 05:25:47 +0000

I have used the zeo as recommended by a naturopathic doc who is helping me resolve some parasympathetic nervous system issues. We used it to confirm that I am getting horrible quality sleep, both in stage patterns and lack of deep sleep. This device is helpful for getting insight to your sleep quality.

To those struggling with lack of good sleep, I would suggest 2 things…a software called f.lux (http://stereopsis.com/flux/)that removes the blue light from your computer screen at night (blue light reduces melatonin), and a treatment called sleep compression (which has also shown to help apnea).

Comment on Validation of Off-The-Shelf Software Development Tools by Zion Technology

Zion Technology — Sat, 10 Dec 2011 07:27:49 +0000

A number of software development methodologies are in use. Our project management identifies the specific nature of the project at hand and then selects the best application development methodology.
We pride ourselves on delivering projects on time, encouraging collaboration, promoting technical excellence and being continuously adaptable. Our projects use commonly accepted plan-driven software development methods that are, however, sufficiently flexible and adaptable to allow the developers to make late changes in the project specifications.
Zion Technology specializes in customized software development for all your business needs. A number of software development methodologies are in use. Our project management identifies the specific nature of the project at hand and then selects the best applicable development methodology.

Comment on Personal EEG-based Communications Device by Synthetic Telepathy – Brain Computer Interface (Paper by Giannis Koromilas) « gkoromilas

Mon, 05 Dec 2011 09:12:28 +0000

[...] Image taken from website RDN Consulting, URL http://rdn-consulting.com/blog/2010/03/13/personal-eeg-based-communications-device/ , accessed 05th of May [...]

Comment on Software Verification vs. Validation by Rickson

Rickson — Tue, 29 Nov 2011 22:30:18 +0000

Hi guys.
Thank you for that informative blog.

Could you please give some more examples for SW validation techniques? I guess fault injection belongs to those. But what else?

Comment on Validation of Off-The-Shelf Software Development Tools by Mitch

Mitch — Tue, 29 Nov 2011 12:02:05 +0000

Hi Bob,
I was very disapointed the first time I read this requirements about OTS in the GPSV. However, we fixed this very easily by splitting OTS in two categories:
-standalone OTS, like compilers, IDE (like visual studio), source control, database engines. We added a section in our software development plan where we have a list of our OTS, the justification why we chose them (usually one criterion is that it is widely used or open-source). We also added a section about looking periodically for updates of the versions of these OTS.
-non standalone OTS, like libraires are verified when integrated in our software, with unit tests, data workflow tests and so on. For this second category, we fall into our ISO 13485 conception procedure. We consider that the OST is verified and validated when it is integrated in our device and when our device is itself verified and validated.
Not necessary to pull one’s hair out with these GPSV requirements!
Regards,
Mitch.
http://www.cm-dm.com

Comment on Validation of Off-The-Shelf Software Development Tools by Yalna

Yalna — Mon, 28 Nov 2011 14:06:00 +0000

Thanks Bob for an informative post.

I’ve got one question:

I need to validate Visual Studio 2010 compiler and have no idea how to approach the task.

How do you validate a compiler?