Every check-in, every target
C++, ROS 2, Python and embedded firmware are built in parallel for ARM64 edge computers, x86 controllers and simulators, then tested on every commit.
Every release built, tested and on the record.
Managed build, test and simulation infrastructure for medical-device and robotics software. We run it on your hardware or ours, and generate the records your quality and regulatory teams need for the FDA pathway.
Built for software that can't fail in the field
Simulation on the critical path
Scripted scenarios, injected faults and synthetic patients run against every release, so no hardware or operating room is needed to find a regression.
One record per release
Source revision, pinned toolchain, test results and approvals are captured in a tamper-proof build record, generated rather than assembled by hand.
Fleet traceability and rollback
Trace any binary in the field back to its commit, and roll back to the last known good build before a bad release reaches hardware.
Failures explained same day
Our AI analyst reads thousand-line build and test logs and returns a plain-language root cause. It advises. Your engineers always decide, and it never trains on your code.
Run by us, defined by you
We build, maintain and operate the pipeline so you skip standing up a platform team. Your team sets the thresholds and owns every decision.
GOVERNANCE & COMPLIANCE
Evidence for the FDA pathway, generated by the build
We supply the infrastructure and the evidence it produces. Your quality and regulatory teams own the submission and decide how the evidence is used. Dev Stream Labs does not write, own or sign regulatory submissions.
- Records designed to support IEC 62304, ISO 13485, ISO 14971, 21 CFR Part 11 and QMSR practices.
- Machine-readable SBOM (SPDX or CycloneDX) per release, for FDA section 524B cybersecurity files.
- Tamper-proof build records that support design history file and V&V traceability.
- A validation package for our own system, to fit your software validation procedure.
- SOC 2 Type II report available on request.
- AI never decides pass or fail. Gates are deterministic measurements against thresholds your team sets.
We follow your procedures.
We don't ask you to adopt ours.
Your engineers keep their existing tests, and we add the tests and simulations that are missing. Your team approves every new test.
Software development
Regression at every check-in, with test summaries and release records generated.
Change control
Every change linked to the build and the tests that cover it.
Configuration management
Every build labeled. Tools and third-party software versioned.
Issue tracking
Reports pre-filled from failing builds. Your team decides each outcome.
Secure by placement: on-premises or private cloud
Regulated source code and device data shouldn't leave your control. Choose where the system runs. We operate it either way.
On your premises
We build, deploy and manage the system in your facility, on top of your hardware. Source and builds stay on your own network.
Your private cloud account
Runs inside a cloud account you own and control. Test data is synthetic, never PHI.
Hosted by us
Managed in our Tier 3 data center when you would rather not run hardware at all, and it can reduce your cost.
Proven on a surgical-robot platform
Real C++ controller code from a robotic navigation system runs through 48 simulated-patient scenarios on every check-in, with the same verdict on Windows, Linux and macOS.
Thirty years of hard builds
We are engineers who have made large, real-time, hardware-in-the-loop codebases build reliably every day, led by founder and CEO Brent Pease (Apple, Bungie, EA). We can also work alongside your team during onboarding to get you running quickly.
Start with your gaps, not our platform.
A working session with your engineering, quality and regulatory leads, then a short discovery that can lead to a pilot proposal.
Talk to our team