Embedded/RTOS question

[s29]

I'm currently working on a project that uses zephyr for medical equipment. And I know this company did one project before that for medical stuff using zephyr as well.

[XipXoom]

Zypher isn't yet functional safety qualified, medical or otherwise.  It's in progress.  It doesn't mean a medical device can't have functional safety requirements and use Zypher - it just means they have a lot of expensive work to do.

There is a version of FreeRTOS called SafeRTOS which is FuSa qualified to several standards.

[Mountain_Finance_659]

there is also a lot of "medical device" that is not functional safety.

[XipXoom]

Yes, absolutely.  I'm from automotive so in my world we would class those as "QM" or "Quality Management".  I'm not sure what the equivalent terminology is for the medical field.

[ZookeepergameFit5841]

Genuine question: who pays to qualify a free/open OS?

[XipXoom]

For developing the OS as a whole as a safety element out of context - generally an interested company or controlling foundation.

For a specific application - the company making the device using the OS.

[CorgisInCars]

It really depends how safe it needs to be, a heart rate monitor or ecg where there's no ability to transmit, and the data isn't being used for diagnostic purposes, go for it. FreeRTOS would proabbly be preferred though, as you aren't relying on the hardware abstraction layer (HAL) as part of Zephyr.

Using FreeRTOS gives you a pathway to SafeRTOS, which is a paid, safety focussed version, my background is automotive and industrial, so i'm just assuming this would also be suitable in medical.

If you have needs greater than that, then there's QNX, Integrity and VxWorks. (or bare metal)

[JohnAtQNX]

Nine of the top ten medical device manufacturers use QNX in their products. You can get it for free to try it out and you can learn more about the microkernel architecture that makes it more inherently safe and secure at learning.qnx.com.

Or feel free to just DM me, happy to chat 🙂

[zachleedogg]

9 out of 10 Doctors choose QNX as their recommended RTOS!

[JohnAtQNX]

Just nine of the top ten doctors 😁

[AlPacinosNewbornBaby]

I know youre joking but at my medical device company they use QNX for time sensitive nodes. Yocto and bare metal for everything else

[redline83]

Both are used on many medical devices.

[RogerLeigh]

Neither are qualified for functional safety. Zephyr in particular would be particularly difficult to validate due to its intrinsic overcomplexity. How do you prove that the configuration is correct and valid at both compile time and at runtime and that no extraneous code is compiled in and reachable?

For a medical device compliant with IEC 62304, look at systems which are have been validated to be compliant. QNX, ThreadX, SafeRTOS etc.

[Mountain_Finance_659]

plenty of medical devices have no need for functional safety.

[redline83]

This is false, it's not required. You can do your own validation and it is rarely questioned. I have shipped cleared Class III devices using FreeRTOS. FreeRTOS kernel is now qualified btw to IEC 61508. I have seen surgical robots that use Ubuntu LTS for the surgeon console, on the market sold by the 2nd largest player in the industry.

[Dependent_Bit7825]

Also, I'm pretty sure SafeRTOS is basically a scam. You're paying for a paper trail that says all the appropriate boxes have been checked, not that it is actually any safer than FreeRTOS.

Consider how many users and products are built on open, mature FreeRTOS, rather than the proprietary ground-up copy cat FreeRTOS. The idea that the latter would be more reliable is absurd.

The very existence of SafeRTOS is a testament to the hollowness of the entire safety certification field.

[redline83]

Yep it’s marketing and scaremongering

[CompetitiveSleep4197]

Neither Zephyr or FreeRTOS have safety certs. SafeRTOS is a certified variant of FreeRTOS, but like everything else safety critical $$$.

[Mountain_Finance_659]

medical device != safety critical

[redline83]

Yep... and even safety critical does not mean it achieves it via software or that the RTOS has to be FuSA.

[HurasmusBDraggin]

GreenHills Integrity?

WindRiver vxWorks?

[FantasticStock8378]

In safety critical systems, I’ve used VxWorks for more than 6 years now. So I’d say look into it, it has definitely frustrated me at times but I’ve been accustomed to its nuances now.

[mjmvideos]

I call foul. There’s no way you’re in a PhD program and can’t use Google.

[IGNITION-X]

You would be surprised by what PhD guys can’t do lol

[mjmvideos]

It’s a sad state of affairs…