Software as a Medical Device (SaMD) Development
Building software that diagnoses, monitors, or guides treatment? We build it with your regulatory path in mind and work alongside your regulatory consultant from the first sprint, so compliance doesn't mean a rebuild later.
Not sure whether your software counts as a medical device? Read our plain-English guide to SaMD vs. non-regulated health software.
SaMD We Build with Your Regulatory Team
We build the software. Your regulatory consultant owns the classification, risk file, and submission. Projects we take on include:
Diagnostic Image Analysis
Models that check, measure, or flag findings in medical images, with documented training data and test results. For Sevamob, we built an engine that checks diagnostic image quality right on the device in 120 ms.
Symptom Assessment & Triage
Apps that assess symptoms and point patients to the right level of care, using clinical logic your medical team signs off.
Dosing & Treatment Calculators
Calculators that recommend doses or treatment steps, with every rule traceable to a clinical source and fully tested.
How We Build Software as a Medical Device
Understand the Medical Purpose
We start with what your software does: diagnose, monitor, or guide treatment. That sets its risk class, so we confirm it with your regulatory consultant before we build.
Plan Around Risk
Your consultant leads risk management. We build the controls they ask for into the product and the UX, not as patches later.
Build It Secure from Day One
Every build includes:
Encryption and role-based access
Audit logs from the first sprint
Documented training and testing for any machine learning
Support Your Submission
We don't file submissions. We supply the engineering input your consultant asks for.
Keep It Running After Launch
Monitoring, security updates, and changes planned so they don't put your clearance at risk.
FAQs
Straight answers on building medical device software.
Not yet. 26bitz doesn't hold ISO 13485 certification. For regulated products, we work within your quality system and alongside your regulatory consultant.
No. Your regulatory consultant owns the submission. We build the software and work with them on what the submission needs from engineering.
Yes. We audit what's there, keep what holds up, and rebuild what can't be traced or tested. MedCycle Network came to us with an AI-built prototype, and in six weeks it had a production backend with audit logs.
SaMD keeps needing work after launch: monitoring, security updates, and changes that don't put your clearance at risk. We plan that with you before launch.
If it diagnoses, monitors, or guides treatment, it likely is. Wellness apps with general health claims usually aren't. Our SaMD guide shows how FDA and EU MDR decide.
Schedule a Consultation with Our Team
Please provide a brief overview of your project and your earliest availability, and we will get back to you as soon as possible.