Windows CE Medical FDA Guidelines

[Mams]

Dear Greats,

We are planning to develop an class 2 based medical device. which is
going to have Windows CE 5.0 (Core License Image) as a base Operating
System.

For FDA approval is it enough if we validate the entire system
including this COTS - Windows CE OS.

Or we need to validate the Windows CE OS separately and submit the test
reports. In this case, will the microsoft provide any support to
generate test reports.

I put this question because validating the Windows CE OS without
Microsoft help is impossible for my understanding. Is there any medical
device based on Windows CE with FDA approval.

avkumar

[Dean Ramsier]

Qualification - I have no experience with FDA requirements, and don't know
specifically what Class 2 requires. But...

Sounds to me like these are questions for the FDA. They are the ones that
will be making this kind of decision. I would not expect any help from
Microsoft, especially since the license specifically forbids the use of CE
in applications where a product malfunction could cause injury or damage.
CE is a general purpose, real time OS intended for the mass market. It is
not targeted at highly regulated applications. MS isn't likely to spend
the resources that would be required for this narrow market segment.

I'd say your best bet is to segregate the system in such a way that the
portion that is regulated by the FDA is very tightly controlled, not running
an OS like CE. Use CE for a less regulated portion of the design.
--
Dean Ramsier - eMVP
BSQUARE Corporation

Post by Mams
Dear Greats,
We are planning to develop an class 2 based medical device. which is
going to have Windows CE 5.0 (Core License Image) as a base Operating
System.
For FDA approval is it enough if we validate the entire system
including this COTS - Windows CE OS.
Or we need to validate the Windows CE OS separately and submit the test
reports. In this case, will the microsoft provide any support to
generate test reports.
I put this question because validating the Windows CE OS without
Microsoft help is impossible for my understanding. Is there any medical
device based on Windows CE with FDA approval.
avkumar

[Henrik Viklund]

This post might be inappropriate. Click to display it.

[Henrik Viklund]

Oh, and just for the record regarding using Windows Embedded products
in medical devices:
http://msdn.microsoft.com/embedded/getstart/devplat/meddevsys/default.aspx

My first CE project was in fact a life-support system (a total
intravenous anaestetic worstation, class III). However, it never made
it to the market due to insuficient funding.

Henrik Viklund

[Dean Ramsier]

The following is excerpted from license.rtf in C:\Program Files\Windows CE
Platform Builder\5.00:


d. Device Limitations. You may not use or include the SOFTWARE, nor any
components thereof, including without limitation any run-times, in the
development of any device or system in which a malfunction would result in
foreseeable risk of personal injury, death or severe physical or
environmental damage. For more information, contact your Microsoft Account
Manager or Distributor, as applicable.


You can use CE in medical devices such as those described in the article, as
long as you comply with the licensing restriction as stated above. Of
course, as long as no one sues MS, they probably don't care.
--
Dean Ramsier - eMVP
BSQUARE Corporation

Post by Henrik Viklund
Oh, and just for the record regarding using Windows Embedded products
http://msdn.microsoft.com/embedded/getstart/devplat/meddevsys/default.aspx
My first CE project was in fact a life-support system (a total
intravenous anaestetic worstation, class III). However, it never made
it to the market due to insuficient funding.
Henrik Viklund

[skindiver]

Does this mean I can sue the manufacturer of my CE MP3 player for
negligence?
They didn't follow the license, I think it damaged my hearing.

Post by Dean Ramsier
The following is excerpted from license.rtf in C:\Program Files\Windows CE
d. Device Limitations. You may not use or include the SOFTWARE, nor
any components thereof, including without limitation any run-times, in the
development of any device or system in which a malfunction would result in
foreseeable risk of personal injury, death or severe physical or
environmental damage. For more information, contact your Microsoft Account
Manager or Distributor, as applicable.
You can use CE in medical devices such as those described in the article,
as long as you comply with the licensing restriction as stated above. Of
course, as long as no one sues MS, they probably don't care.
--
Dean Ramsier - eMVP
BSQUARE Corporation

Post by Henrik Viklund
Oh, and just for the record regarding using Windows Embedded products
http://msdn.microsoft.com/embedded/getstart/devplat/meddevsys/default.aspx
My first CE project was in fact a life-support system (a total
intravenous anaestetic worstation, class III). However, it never made
it to the market due to insuficient funding.
Henrik Viklund

[Henrik Viklund]

Yes, you're correct. What I was trying to say (my personal view) is
that if you're in compliance with FDA regulations you're in compliance
with the above paragraph. The whole point of FDA regulations is to
ensure that the device is still safe no matter what fails on the
device.

Henrik Viklund

[Alex]

Post by Dean Ramsier
The following is excerpted from license.rtf in C:\Program Files\Windows CE
d. Device Limitations. You may not use or include the SOFTWARE, nor any
components thereof, including without limitation any run-times, in the
development of any device or system in which a malfunction would result in
foreseeable risk of personal injury, death or severe physical or
environmental damage. For more information, contact your Microsoft Account
Manager or Distributor, as applicable.
You can use CE in medical devices such as those described in the article, as
long as you comply with the licensing restriction as stated above. Of
course, as long as no one sues MS, they probably don't care.

Well Microsoft themselves seem happy about this one:
http://www.microsoft.com/windows/embedded/testimonials/greer.mspx
And if a 90-ton crane toppling over is not a foresseable risk of
personal injury, death or severe physical or environmental dammage, what is?

[Steve Maillet (eMVP)]

For more information, contact your Microsoft Account Manager or
Distributor, as applicable.

That's the key phrase as there IS a licensing that does allow that but must
be specifically requested and signed off. NOTE: I've never had anyone doing
that but have been told by MS that it does exist and can be done. If I
recall correctly Bill G. himself made that announcement at the San Diego
DevCon launch event for Windows CE V5.0

[A.User]

We too have used CE in a Class II medical device and we have several more in
development.
We do not use it for any "Safety" related sub-system ... but its great for
smart UI stuff.

Post by Henrik Viklund
Oh, and just for the record regarding using Windows Embedded products
http://msdn.microsoft.com/embedded/getstart/devplat/meddevsys/default.aspx
My first CE project was in fact a life-support system (a total
intravenous anaestetic worstation, class III). However, it never made
it to the market due to insuficient funding.
Henrik Viklund

[Steve Maillet (eMVP)]

Clarification:
"especially since the license specifically forbids the use of CE
in applications where a product malfunction could cause injury or damage."
As of V5.0 this is not true. MS has stated that you can get licensing that
allows that, but it is specifically designed to place ALL liability for the
system and it's parts on you.