Windows CE Operating System - Implantable Blood Pump and a Software Accessory Device

D

d4fl0w

#1
I am consulting a company which is currently working on a new implantable device for the american market. The product consists of an implantable blood pump and an software accessory device. The medical device is likely to be Class III and therefore will need PMA approval. Our problem is we have chosen Windows CE as operating system for the accessory and are not sure how to provide proper safety documentation for the operating system such as risk analysis. Is it possible that Windows CE has proven itself as safe and we can refer to its certification? What documentation is needed for the operating system?

Thank you for your help
 
Elsmar Forum Sponsor

c.mitch

Quite Involved in Discussions
#3
Re: Windows CE Operating System - Implantable Blood Pump and a Software Accessory Dev

Hello D4,

I'm afraid you never get any proof of safety about this OS from its manufacturer or any 3rd party.
If you're lucky, there is already an substentially equivalent device, which is FDA cleared and uses Windows CE or other OS of the same generation like Palm OS. Then my opinion is that you can proove the safety of your product by refering to clinical/bibliographic data from this/these devices. But I think there is little chance to find one.
If you're not lucky, there is a possibility to verify by yourself that the OS you choose fits your intended use. Read the sentence in section 6.3 of GPSV: "Where necessary validation information is not available from the vendor, the device manufacturer will need to perform sufficient system level "black box" testing to establish that the software meets their "user needs and intended uses.".
You can do so by doing technical tests like testing the response time of the OS to data transmission, the response time to refresh the screen, the behaviour when OS is stressed (low memory, 4 processes requiring 100% CPU at he same time) and so on, with simple programs and fake data. By doing such tests, you can proove that you don't loose data, you don't miss an information on the screen and that the OS behaves like expected.
What I want to show is that if the OS you chose fits the technical requirements of your device, then it is safe to use it.
TO sum-up:
Intended use --> functional requirements on software --> technical requirements on software in its technical environment.
If you verify the software and its technical environment (including OS) behave like expected, then there should not have issue about OS.

Regards,
Mitch.
 

glork98

Involved In Discussions
#4
Re: Windows CE Operating System - Implantable Blood Pump and a Software Accessory Dev

This is very familiar.

The issue becomes the level of safety that is needed from the Windows CE software. If it's safety-critical the Windows CE license forbids its use. Also, you'll never validate its functionality.

If it is purely monitoring but no configuration you may be able to make a CE-based product fly.
 
#5
Re: Windows CE Operating System - Implantable Blood Pump and a Software Accessory Dev

If it's safety-critical the Windows CE license forbids its use.
I seem to remember that a US court ruled that a manufacturer cannot prevent a product being used for what ever purpose the legitimate owner wanted. This, however, was in a case of a chemical being used to make fuel octane booster so it may not be totally transferable.

However, if the operating system is in (say) the clinicians programmer for the implanted pump it should be possible to have safe operation (of the pump) even with a defective programmer, which reduces the likely Level of Concern. Then the guidance already linked to on the use of Of-the-Shelf software covers the requirements.
 

glork98

Involved In Discussions
#6
Re: Windows CE Operating System - Implantable Blood Pump and a Software Accessory Dev

I should say that I'm using WIndows CE inside the box of a Class III device. We have a separate processor that performs all safety-critical work and the GUI program on CE cannot negatively affect the other processor. We're using 62304 so the CE use is Class A and non-critical.
 

glork98

Involved In Discussions
#7
Re: Windows CE Operating System - Implantable Blood Pump and a Software Accessory Dev

(I received a question about this approach)

The product is moving into clinical trials in the US and Europe and received the needed CE Mark and an IDE from the FDA.
 
V

vsthakkar

#8
Re: Windows CE Operating System - Implantable Blood Pump and a Software Accessory Dev

Thank you very much for your reply.. We are planning to walk on the same path so were looking at some predicate devices..

How much headache V&V of Windows CE was? Would you take the same route again for another project?
 

glork98

Involved In Discussions
#9
Re: Windows CE Operating System - Implantable Blood Pump and a Software Accessory Dev

I'd take the same general approach but use XP Embedded or similar. Maybe Linux. WinCE was a pain for Silverlight support and we had some BSP problems when the manufacturer of the OTS board switched audio chips.

The "V&V" was all validation of the functionality against the requirements. The architecture document was reviewed to determine that all the code was Class A so no unit tests, code reviews or design docs were needed.
 
Thread starter Similar threads Forum Replies Date
J Google Offers Peek at Operating System, a Potential Challenge to Windows After Work and Weekend Discussion Topics 2
Jim Wynne Windows 11 is Coming--Is Your Computer Ready? Coffee Break and Water Cooler Discussions 16
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
Ninja Windows 10 100 % disk use after update Coffee Break and Water Cooler Discussions 33
G Windows 10 OS build Software Validation US Food and Drug Administration (FDA) 1
Claes Gefvenberg Windows 8.1 - Pros & cons, hints & tips. After Work and Weekend Discussion Topics 5
Jim Wynne Windows 8.1: No Security Updates Without Update 1 After Work and Weekend Discussion Topics 4
Marc Windows XP EOL scamware After Work and Weekend Discussion Topics 1
insect warfare IRS pays Microsoft for Windows XP support After Work and Weekend Discussion Topics 2
insect warfare Windows XP support ends today (April 8, 2014) After Work and Weekend Discussion Topics 2
T Will the End of Windows XP Support affect anything in AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
K COTS Validation: Should we validate Windows after each Update? IEC 62304 - Medical Device Software Life Cycle Processes 3
G When to use a flyscreen on windows? Food Safety - ISO 22000, HACCP (21 CFR 120) 8
Jim Wynne Have you tried Microsoft Windows 8? After Work and Weekend Discussion Topics 25
Marc The "I am calling you from Windows" telephone scam After Work and Weekend Discussion Topics 13
Z Tutor For Windows--CMM Software--Is anyone familiar with it? Calibration and Metrology Software and Hardware 2
Stijloor Importing Address Books (Thunderbird and Outlook Express) into Windows Live Mail After Work and Weekend Discussion Topics 3
Marc 66% of All Windows Users Still Use Windows XP After Work and Weekend Discussion Topics 19
Stijloor Briefcase on Windows 7... After Work and Weekend Discussion Topics 29
S Google phasing out use of Windows over security concerns After Work and Weekend Discussion Topics 0
Claes Gefvenberg Microsoft Windows users: Which windows version are you using? March - April 2010 After Work and Weekend Discussion Topics 37
S Software changes (windows 2007 compatible) notification to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Jim Wynne February 2010 Windows Update Causes BSOD for Alureon Rooted XP Users After Work and Weekend Discussion Topics 8
S Does Windows Service Pack (SP-3) upgrade need supplementary 510(k) submission?? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Marc FSF Attacks Windows 7's "Sins" In New Campaign After Work and Weekend Discussion Topics 1
F Is self-serve password reset for Windows considered for validation under CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 2
A If you use Magic Windows Professional SPC Software. Please Reply Quality Manager and Management Related Issues 1
Marc Cloning a Windows XP drive and Booting from a Firewire Clone After Work and Weekend Discussion Topics 4
DanteCaspian Looking for Windows Media Player Help After Work and Weekend Discussion Topics 3
bobdoering From MS: Guidance on Windows Deployments for Business Customers After Work and Weekend Discussion Topics 0
Stijloor Microsoft's Ballmer: Windows 7 is nearly final After Work and Weekend Discussion Topics 13
A Critical Windows Patch - All Version - 24 October 2008 After Work and Weekend Discussion Topics 6
Marc NNTP Usenet Readers for Windows - Suggestions and Reviews After Work and Weekend Discussion Topics 4
ScottK Safari for Windows is out today. After Work and Weekend Discussion Topics 9
Stijloor The 20 (Mostly Free) Downloads for MS Windows Computers You Can't Do Without After Work and Weekend Discussion Topics 2
Claes Gefvenberg Upgrading the Windows OS PC? After Work and Weekend Discussion Topics 29
B Which Quality system? Company produces aluminum windows - No automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Claes Gefvenberg So, how about Microsoft Windows Vista? After Work and Weekend Discussion Topics 85
Marc Vinyl Replacement Windows - 'Weeping' condensation at Glass / Vinyl Interface After Work and Weekend Discussion Topics 20
J MS Windows XP Pro Hard Drive Defrag (defragmentation) question After Work and Weekend Discussion Topics 26
Marc CrossOver public beta: Allows Windows apps to run without Windows on Intel-based Macs After Work and Weekend Discussion Topics 0
Marc Another Windows Vista Feature Bites the Dust - PC-to-PC synchronization After Work and Weekend Discussion Topics 1
Marc Intel-Macs owners now have an official second OS option - Windows XP After Work and Weekend Discussion Topics 10
B Keeping your Windows PC running Smoothly After Work and Weekend Discussion Topics 18
Marc Extremely Critical Windows Security Hole - 29 December 2005 After Work and Weekend Discussion Topics 0
Marc Dell's Open PC Costs More Than Windows Box After Work and Weekend Discussion Topics 5
Q Windows vs. Linux - Just wondering if any Covers use or have tried Linux After Work and Weekend Discussion Topics 6
Marc What is the best 'Windows' laptop (notebook) computer? After Work and Weekend Discussion Topics 19
Marc Hackers Tune In to Windows Media Player - Two new Trojans After Work and Weekend Discussion Topics 4
Geoff Cotton MS Windows - Bagle-A Virus Alert - 18 Jan 2004 After Work and Weekend Discussion Topics 17

Similar threads

Top Bottom