FreeRTOS / SafeRTOS in a Medical Device

C. J. Clegg wrote:
> Our team is working on the early stages of development of a class 2
> medical device using a low-end ARM7 controller.
>
> Our plan is to do much of the preliminary development using FreeRTOS
> and then migrate to SafeRTOS after we have proved feasibility, on the
> theory that SafeRTOS will be easier to get past the FDA.
>
> Today, I got a brief look at what SafeRTOS costs ... something on the
> order of $60,000 (!!!!) including the documentation and test suites to
> support FDA approval (I think they call it their "Design Assurance
> Pack" or something close to that).
>
snip

Disclaimer:  We produce the Validation Suites for uCOS, so my opinion may 
not be completely unbiased.

You should also be aware, that although FreeRTOS has been ported to a number 
of processors, according to their web site SafeRTOS has only been certified 
on one.  If you are not using that specific chip/compiler combination your 
expense is likely to be much higher.

Scott
Validated Software

"Not Really Me" <scott@validatedQWERTYsoftware.XYZZY.com> wrote in message 
news:6p00cvF5lsbiU1@mid.individual.net...

> Disclaimer:  We produce the Validation Suites for uCOS, so my opinion may 
> not be completely unbiased.
>
> You should also be aware, that although FreeRTOS has been ported to a 
> number of processors, according to their web site SafeRTOS has only been 
> certified on one.


I will have a look at this, it seems very missleading or out of date.  Our 
own original component certification by T&#4294967295;V was performed on one particular 
configuration baseline, using a particular compiler, and a particular 
processor [the only way it can be done].  It does not, or at least is not 
supposed to, mean this is the only configuration baseline that is available.

> If you are not using that specific chip/compiler combination your expense 
> is likely to be much higher.

Not so, as far as I know the target platfrom is not a price differentiator, 
but then I'm not on the commercial side so please don't quote me on that!


-- 
Regards,
Richard.

+ http://www.FreeRTOS.org Designed for Microcontrollers
17 official architecture ports, more than 6000 downloads per month.

+ http://www.SafeRTOS.com
Certified by T&#4294967295;V as meeting the requirements for safety related systems. 

Not Really Me wrote:
> 
... snip ...
> 
> You should also be aware, that although FreeRTOS has been ported
> to a number of processors, according to their web site SafeRTOS
> has only been certified on one.  If you are not using that
> specific chip/compiler combination your expense is likely to be
> much higher.

And I have my doubts.  Where is the source of this test suite?  To
what independant international standard does it adhere?  If this
stuff is available, why can't the users adapt it to other systems,
and publish their work?  Etc. etc.

-- 
 [mail]: Chuck F (cbfalconer at maineline dot net) 
 [page]: <http://cbfalconer.home.att.net>
            Try the download section.

In message <492B1667.7C3E0F8D@yahoo.com>, CBFalconer 
<cbfalconer@yahoo.com> writes
>Not Really Me wrote:
>>
>... snip ...
>>
>> You should also be aware, that although FreeRTOS has been ported
>> to a number of processors, according to their web site SafeRTOS
>> has only been certified on one.  If you are not using that
>> specific chip/compiler combination your expense is likely to be
>> much higher.
>
>And I have my doubts.  Where is the source of this test suite?

You don't need the source.

> To
>what independant international standard does it adhere?

IEC61508

>If this
>stuff is available, why can't the users adapt it to other systems,
>and publish their work?  Etc. etc.

You don't understand safety critical work do you?
The legalities involved mean you can't tinker with the source without a 
full and complete re-test. This isn't a hobby or a bit of fun. Lives 
depend on it.

-- 
\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\
\/\/\/\/\ Chris Hills  Staffs  England     /\/\/\/\/
\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/

"Chris H" <chris@phaedsys.org> wrote in message 
news:PJGV08AlB7KJFAvq@phaedsys.demon.co.uk...
> In message <492B1667.7C3E0F8D@yahoo.com>, CBFalconer 
> <cbfalconer@yahoo.com> writes
>>Not Really Me wrote:
>>>
>>... snip ...
>>>
>>> You should also be aware, that although FreeRTOS has been ported
>>> to a number of processors, according to their web site SafeRTOS
>>> has only been certified on one.  If you are not using that
>>> specific chip/compiler combination your expense is likely to be
>>> much higher.

As I already stated - that is not the case on both counts.

>>
>>And I have my doubts.  Where is the source of this test suite?

I think a little confusion is creeping into these threads.  I cannot comment 
on this question properly because I don't really understand what you are 
asking.  The tests are very specific to the product (not generic), and cost 
a whole load of money to produce.  We are not talking about an open source 
code base here.

> You don't need the source.

Again, I don't understand this comment so might be ansering the wrong 
questions.

*If* this is referring to the test suite that comes with a validated RTOS 
(be it SafeRTOS, Validated Software or whatever) then you most definately do 
need the source code to be able to qualify the product in your own 
environment, on your hardware, with your compiler, demonstrate that the 
required coverage is obtained, etc.......and we provide the source code to 
paying customer.

>
>>If this
>>stuff is available, why can't the users adapt it to other systems,

They can.

>>and publish their work?  Etc. etc.

Because we would sue you and your childeren would go unfed ;o)  I really 
think we are talking at cross purposes though, so maybe not.

-- 
Regards,
Richard.

+ http://www.FreeRTOS.org Designed for Microcontrollers
17 official architecture ports, more than 6000 downloads per month.

+ http://www.SafeRTOS.com
Certified by T&#4294967295;V as meeting the requirements for safety related systems. 

Chris H wrote:
> <cbfalconer@yahoo.com> writes
>
... snip ...
>
>> And I have my doubts.  Where is the source of this test suite?
> 
> You don't need the source.

I have difficulties reading and evaluating the tests without it.

> 
>> To what independant international standard does it adhere?
> 
> IEC61508
> 
>> If this stuff is available, why can't the users adapt it to
>> other systems, and publish their work?  Etc. etc.
> 
> You don't understand safety critical work do you? The legalities
> involved mean you can't tinker with the source without a full
> and complete re-test. This isn't a hobby or a bit of fun. Lives
> depend on it.

You don't seem to understand reading.  Who mentioned 'tinkering'?

-- 
 [mail]: Chuck F (cbfalconer at maineline dot net) 
 [page]: <http://cbfalconer.home.att.net>
            Try the download section.

"FreeRTOS.org" wrote:
> "Chris H" <chris@phaedsys.org> wrote:
>> <cbfalconer@yahoo.com> writes
>>
... snip ...
>>
>>> If this stuff is available, why can't the users adapt it to
>>> other systems,
> 
> They can.
> 
>>> and publish their work?  Etc. etc.
> 
> Because we would sue you and your childeren would go unfed ;o) 
> I really think we are talking at cross purposes though, so maybe
> not.

Oh?  You would consider publishing something like:

  In version 123.456, lines 789 thru 792:

    delete "in blah blah blah"
    and substitute "in blah gubris"
    and add "otherwise frabble"
    to meet standard provision 6.3.4.5.

a copyright violation?  I suspect you would have trouble finding a
legal firm to represent you.

-- 
 [mail]: Chuck F (cbfalconer at maineline dot net) 
 [page]: <http://cbfalconer.home.att.net>
            Try the download section.

>> Because we would sue you and your childeren would go unfed ;o)
>> I really think we are talking at cross purposes though, so maybe
>> not.
>
> Oh?  You would consider publishing something like:
>
>  In version 123.456, lines 789 thru 792:
>
>    delete "in blah blah blah"
>    and substitute "in blah gubris"
>    and add "otherwise frabble"
>    to meet standard provision 6.3.4.5.
>
> a copyright violation?  I suspect you would have trouble finding a
> legal firm to represent you.

Firstly, this was not supposed to be a serious comment, and second I still 
don't understand where you are coming from.

If I was to licensed you (with usual clauses about no publication or 
re-distribution etc.) under NDA some proprietary source code that included a 
test suite and you saw fit to publish this, yes I think it would be very 
easy to find somebody to represent me (or whoever owned the software, not 
actually me in this case).  I'm sure you would agree with this, which just 
proves my other point that I think we are talking about different things.

If on the other hand you are saying that somebody could take open source 
code and publish a load of patches to 'upgrade' the code to be compliant 
with some safety related standard or other then, I would not have a problem 
with that.  Although I would say it would be of little value for actual use 
in a highly safety critical environment as the source code is probably 5% of 
the evidence required, and 0% of the evidence required unless you have 
complete lifecycle evidence to go with it.

-- 
Regards,
Richard.

+ http://www.FreeRTOS.org Designed for Microcontrollers
17 official architecture ports, more than 6000 downloads per month.

+ http://www.SafeRTOS.com
Certified by T�V as meeting the requirements for safety related systems. 

In message <j97Xk.93206$E41.21329@text.news.virginmedia.com>, 
FreeRTOS.org <noemail@given.com> writes

>If on the other hand you are saying that somebody could take open source
>code and publish a load of patches to 'upgrade' the code to be compliant
>with some safety related standard or other then, I would not have a problem
>with that.
> Although I would say it would be of little value for actual use
>in a highly safety critical environment as the source code is probably 5% of
>the evidence required, and 0% of the evidence required unless you have
>complete lifecycle evidence to go with it.

Source code is less than 5% of the evidence required and 0% unless you 
have the complete life cycle evidence to go with it....

That is what I have been trying to say.

Life cycle evidence is an important part of things. In a commercial 
compiler and RTOS companies they have full control and full history at a 
level you don't normally get in Open Source Projects.

61508 requires a coding subset, coding standard  and static analysis for 
using C, never mind the other testing and proofs.

Also changes, any changes, require FULL regression testing. This would 
be a full build test suite, language compliance, test of language 
extensions, maths tests etc.

The people I know who do who want they are doing have described the GCC 
"test suite" as a "ragtag group of tests" and "very weak" compared to 
most commercial compiler build testing.  Added to which most GCC 
compilers never get anywhere hear a recognised Language test suite. .


-- 
\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\
\/\/\/\/\ Chris Hills  Staffs  England     /\/\/\/\/
\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/

> The people I know who do who want they are doing have described the GCC 
> "test suite" as a "ragtag group of tests" and "very weak" compared to most 
> commercial compiler build testing.  Added to which most GCC compilers 
> never get anywhere hear a recognised Language test suite. .


I think we are mixing threads up here - the "ARM IDE" thread was on this 
topic.

-- 
Regards,
Richard.

+ http://www.FreeRTOS.org Designed for Microcontrollers
17 official architecture ports, more than 6000 downloads per month.

+ http://www.SafeRTOS.com
Certified by T�V as meeting the requirements for safety related systems.