bitcron is the embedded development partner that takes founders from concept to FDA clearance — with AI built into the stack, not bolted on. One team across firmware, electronics, AI/ML, and regulatory, instead of stitching together five vendors.
One team for firmware to regulatory.
◆ Why bitcron
Stitching firmware, electronics, AI, and regulatory across separate vendors leaks time, context, and risk at every handoff. We collapse that into one accountable team — built for startup speed and clearance-grade rigor.
Full-stack under one roof
No vendor-to-vendor translation layer, no finger-pointing when the model, the board, and the submission have to agree. Decisions get made once, by the people who own the whole device.
Startup speed
Tight loops, real prototypes, and an embedded team that operates like part of yours.
Audit-ready from day one
The Design History File grows alongside the device — not reconstructed the week before a submission.
De-risked submissions
Pathway, predicates, and evidence are planned from the first sketch, so verification and validation confirm a case you've been building all along. Fewer surprises at the FDA, fewer expensive redesigns.
Single point of contact
When the same team owns silicon, software, and submission, accountability stops falling between the cracks — and you keep your time for building the company, not managing a vendor matrix.
◆ The differentiator
Medical AI lives or dies on whether it can be verified, validated, and defended to a regulator. We design models and the regulatory case for them at the same time.
AI / ML engineering
From signal to inference to clearance: we own the full AI lifecycle inside the device — data pipelines, model design, on-device deployment, and the verification & validation evidence that makes it defensible. Regulatory thinking is in the loop from the first dataset, so the model you ship is the model you can document.
On-device · edge ML
Quantized, latency-bound models that run on the embedded target — private by default, no round trip to the cloud.
SaMD
Standalone clinical software architected to IEC 62304, with intended-use and risk baked into the design.
Model V&V
Test protocols, datasets, and performance evidence that demonstrate the model does what it claims — repeatably.
FDA PCCP
Predetermined Change Control Plans that let models improve post-clearance — within bounds the FDA already agreed to.
Signal processing · data pipelines
DSP front ends, sensor fusion, and reproducible data pipelines — the unglamorous foundation that decides whether a medical model is ever trustworthy in the first place. Versioned data, traceable from raw capture to the prediction it produced.
◆ Technical domains
Deep, hands-on expertise in the disciplines that make real medical hardware work — and earn clearance.
01
Motion control, safety interlocks, real-time loops.
02
RF-therapy and laser energy delivery with precise dosing.
03
Ultra-low-power stimulation and long-life implant design.
04
BLE and RF links for connected, monitored devices.
05
Efficient, safe power electronics for demanding loads.
06
Low-noise analog front ends for trustworthy measurement.
07
Deterministic, testable firmware to IEC 62304.
08
Companion apps and connected workflows for clinicians.
◆ Compliance
We build to the standards that submissions are graded against — and keep the evidence current as the device evolves, not reconstructed at the end.
Design History File
Requirements, risk analysis, design inputs and outputs, and verification evidence accumulate in the DHF as the device takes shape — so when it's time to file, the story is already written, traceable, and consistent across hardware, software, and AI.
Standards we build to
◆ How it works
A focused engagement model that designs the device, the AI, and the compliance story together — built for speed and lower submission risk.
Assess
Design
Validate
Let's talk
Tell us where you are — a napkin sketch, a working prototype, or a stalled submission. We'll tell you, honestly, how an AI-first full-stack team could help you get to clearance faster. No pressure, just a conversation between engineers.