FDA CDRH compliance and IEC 62304
joel at rtems.org
Sat Mar 3 13:45:14 UTC 2018
On Mar 3, 2018 2:42 AM, "Russell Haley" <russ.haley at gmail.com> wrote:
I'm looking into compliance for operating systems used in medical
devices and I was wondering if there is information on *any*
regulatory compliance for RTEMS? FDA compliance would be icing on the
There have been multiple versions of RTEMS which have had subsets qualifed
by ESA to their standard which looks like DO-178. The last version they did
this for was 4.8. They sponsored a lot of the SMP effort and are supposed
to be in the process of what they call pre-qualification. We can't do real
qualification without a final system. We are hoping the discussions we've
had will result in the artifacts finding their way back to the open
project. But we're still figuring the best way to manage these types of
artifacts in an open project. Especially one with the requirements to use
open and free tools.
Additionally NASA IV and V persons have giving have given us suggestions on
an outline for an RTEMS software engineering handbook. This could initially
be populated with information from the wiki. The goal here is to have this
type of information in a real document which can be placed under Version
Control. For example, our coding-style would be moved from the wiki to a
section of this document. Are content hasn't been graded, but at this point
we believe you can't easily find our homework.
Scott Zemerick gave a presentation on this at the Flight Software Workshop
in December. We need volunteers to do the initial population of this per
Someone more familiar with the European Space Agency efforts can speak to
what's going on right now.
As a project, we need help and how to manage requirements, traceability,
Etc in an open-source environment without dependence on very expensive tools
I also know RTEMS has been used in medical devices so those users must have
done something. Hopefully they will also comment specifically on anything
they've had to do.
Personally, I think this is an important area for the project but it
requires specialized expertise along with some investment of real time and
money. Overall the goal is for the open project to own and maintain the
artifacts so this is quite possible. Is challenging and we would be the
first open source project to do this in the open.
Notice how I snuck in real time there. :)
Alternatively, has anyone ever run static or dynamic analysis on RTEMS
(with or without libbsd)?
We have run Coverity as part of the Scan program. I have run CodeSonar from
Grammatech. Others have made reports from open source tools. Between early
work by me and recent work by Gaisler, clang is close to usable on the
The test suite itself has high coverage but we don't have the
infrastructure in place to automatically run it periodically and publish
results. 4.10 was near 100% generated instruction coverage and above 95%
branch coverage. Branch coverage being defined as for each branch
instruction, we saw it taken and not taken.
This is all important and we have done our best to gear various efforts to
nibbling at it. But it needs help.
If you want to talk about this sometime, email me privately and we can
arrange a phone call or WebEx.
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