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Software as a Medical Device, built to survive scrutiny.

IEC 62304-compliant development, risk management, and submission-ready documentation — for SaMD that clears FDA review and holds up in the field.

Brief us ↗ See work
WHAT WE BUILD

We build Software as a Medical Device for diagnostic, monitoring, and clinical decision-support applications. IEC 62304 lifecycle discipline, ISO 14971 risk management, and 510(k)/De Novo submission support — engineered so the software is defensible to a reviewer, not just functional for a user.

Problem · approach · outcome.

HOW WE RUN THIS KIND OF WORK
01 · PROBLEM

SaMD is judged on regulatory defensibility, not just clinical performance.

A model that predicts well but can't produce a traceable design history file stalls in review. Real SaMD risk lives in the development record: requirements traceability, verification evidence, and a risk file that maps every hazard to a mitigation.

02 · APPROACH

Build the software inside the quality system, not alongside it.

We run full IEC 62304 software lifecycle processes from day one — requirements, architecture, verification, and risk management under ISO 14971 — so the design history file is a byproduct of how we build, not a document assembled afterward.

03 · OUTCOME

Submission-ready documentation reviewers don't send back.

Clients move through 510(k) and De Novo review without documentation deficiencies. Design history files, risk management files, and verification records are complete, traceable, and current.

What we ship.

6 MODULES · EXTENSIBLE
F-01

SaMD Classification & Regulatory Strategy

IMDRF risk-based classification, predicate analysis, and a submission pathway (510(k), De Novo, PMA) mapped before a line of code ships.

F-02

IEC 62304 Development Lifecycle

Software requirements, architecture, and unit-level design controlled under a documented IEC 62304 process, with traceability from requirement to test.

F-03

Risk Management (ISO 14971)

Hazard analysis, risk controls, and a risk management file that maps every identified hazard to a verified mitigation.

F-04

Clinical Evaluation & Validation

Clinical validation studies and usability evaluation under IEC 62366, designed to generate the evidence a submission actually needs.

F-05

510(k) / De Novo Submission Support

Submission packages assembled and reviewed against FDA guidance, with responses to additional information requests handled directly.

F-06

Post-Market Surveillance

Complaint handling, adverse event tracking, and post-market clinical follow-up built into the software's operational lifecycle.

DEV STACK
PythonC++ReactSwift
STANDARDS
IEC 62304ISO 14971ISO 13485IEC 62366
QUALITY SYSTEM
Design ControlsDHFTraceability
CLOUD (HIPAA)
AWSAzureGCP

Building SaMD your reviewers won't send back?

CUSTOM SAMD · 12-WEEK REGULATORY STRATEGY
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Custom SaMD FAQs.

Q-01Have you taken SaMD through FDA clearance before?+
Yes — we've supported 510(k) submissions and IEC 62304-compliant development for diagnostic and monitoring software. Our portfolio includes AI-powered risk prediction and clinical decision-support projects.
Q-02What's the difference between SaMD and a general health app?+
SaMD makes or informs a clinical decision — diagnosis, monitoring, treatment guidance — which brings it under FDA (or equivalent) regulation as a medical device. A general wellness app that doesn't diagnose or treat typically falls outside that scope. Classification determines which controls, documentation, and pathway apply.
Q-03Do you handle the regulatory submission, or just the engineering?+
Both. We build the software under IEC 62304 controls and assemble the submission package — including the design history file, risk management file, and clinical evidence — then support responses to FDA information requests.
Q-04How do you manage risk documentation under ISO 14971?+
We run hazard analysis alongside development, not after it, so every identified hazard is tied to a specific risk control and verification test. The risk management file stays a living document that's updated as the software changes.
Q-05How long does a SaMD development engagement take?+
Regulatory strategy and classification typically take twelve weeks. Full IEC 62304 development through a submission-ready package is scoped separately based on device classification and clinical evidence requirements.