FDA SaMD Software Development Services

Overview

Custom SaMD Solutions, done the Emorphis Health way

Building Software as a Medical Device means every requirement, risk, and test case has to trace back to patient safety. We run IEC 62304-aligned lifecycles from day one so your submission package is a byproduct of good engineering, not a scramble at the end.

Teams hire our SaMD software development team specifically to avoid the two most common failure modes in medical device software: under-documented engineering that stalls at FDA review, and over-engineered process that grinds product velocity to a halt. Our IEC 62304 and ISO 13485-aligned lifecycle is scaled to your software safety classification, so Class A tools move fast and Class C devices get the rigor they require.

MedTech ManufacturersDiagnostic AI CompaniesDigital Therapeutics TeamsRegulatory Affairs Leaders

Risk Classification

IEC 62304 software safety classification (A/B/C) and ISO 14971 risk management aligned to your intended use.

IEC 62304ISO 14971

Design Controls

Requirements traceability, design reviews, and verification & validation built into every sprint.

Design ControlsV&V

510(k) / De Novo Support

Technical documentation and evidence packages structured for FDA premarket submission.

510(k)De Novo

Quality Management System

ISO 13485-aligned QMS processes covering document control, CAPA, and change management.

ISO 13485CAPA

Cybersecurity for Medical Devices

FDA premarket cybersecurity documentation, SBOM generation, and threat modeling built into the release process.

SBOMThreat Modeling

Post-Market Surveillance

Complaint handling, adverse event tracking, and software maintenance aligned to post-market obligations.

SurveillanceCAPA

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Documentation Discipline

Documentation that's generated, not reconstructed

Design history files, traceability matrices, and risk files are maintained continuously as artifacts of the development process — so nothing needs to be rebuilt for an audit or submission.

Live requirements-to-test traceability matrix
Continuous design history file updates
Audit-ready exports at any milestone

Requirements traced to verification evidence100%

Late-stage documentation scrambles0

Operational QMS

A QMS your team can actually operate

We implement ISO 13485-aligned processes sized to your organization, so quality management supports velocity instead of becoming a bottleneck.

Right-sized document control & SOPs
CAPA workflow integrated with engineering
Change control tied to version releases

Aligned QMS structureISO 13485

CAPA & change trackingContinuous

Classification & Pathways

Where your software lands on the risk spectrum

IEC 62304 classification and FDA pathway choice both flow from the same question: what happens if the software fails? This is the framework we use to answer it with you.

Safety Class	Risk of Harm	Example	Documentation Depth
Class A	No injury or damage to health possible	Clinical reference or scheduling utility	Baseline design & development records
Class B	Non-serious injury possible	Clinical decision support, dosage calculators	Full design controls + verification testing
Class C	Death or serious injury possible	Diagnostic imaging AI, closed-loop therapy control	Full V&V, risk traceability & formal design reviews

510(k)

Substantial equivalence to a predicate device — the most common route for incremental SaMD innovation.

De Novo

For novel, low-to-moderate risk devices with no existing predicate on the market.

PMA

Premarket approval for the highest-risk Class III devices requiring full clinical evidence review.

How We Work

A delivery process built around clinical accountability

Every engagement follows the same disciplined path from discovery to ongoing support — adapted, not reinvented, for each client.

Intended Use

Define intended use & risk classification.

Planning

Software development & risk management plans.

Design & Build

Traceable requirements-driven development.

V&V Testing

Verification, validation & usability testing.

Submission

Technical file & regulatory submission support.

Post-Market

Surveillance, CAPA & maintenance releases.

Standards & Stack

Technology and compliance frameworks we build on

Engineering Practices

Requirements TraceabilityStatic AnalysisAutomated V&VSBOM GenerationVersion ControlChange Control

Regulatory Frameworks

IEC 62304ISO 14971ISO 13485FDA 510(k)FDA De NovoEU MDR

FAQ

Common questions about Custom SaMD Solutions

Which FDA pathways do you support?

We support 510(k) and De Novo pathway preparation, including predicate analysis, technical documentation, and cybersecurity submission requirements. Regulatory strategy is typically confirmed with your regulatory counsel.

What software safety class do you design for?

We classify software per IEC 62304 (Class A, B, or C) based on the potential for harm from a software failure, and scale documentation rigor accordingly.

Do you support EU MDR alongside FDA pathways?

Yes, our design control and risk management processes are structured to support both FDA and EU MDR technical documentation requirements in parallel.

Can you help with an existing product that needs a QMS retrofit?

Yes — we run a gap assessment against ISO 13485 and IEC 62304, then implement a remediation plan prioritized by risk and audit timeline.

How much does SaMD software development cost?

Cost depends heavily on software safety classification — a Class C device requires far more V&V and documentation than Class A, so we scope cost after an initial risk classification review.

How do I hire a SaMD software development company?

Start with an intended-use and risk classification workshop, which lets us scope the right level of design controls and documentation before committing to a full development timeline.

How long does it take to get FDA clearance for SaMD?

Timelines vary by pathway and class, but 510(k) submissions for Class B software typically take several months of review after a complete technical file is submitted.

Do you provide the full technical documentation package for submission?

Yes, our design control process produces the design history file, risk management file, and V&V evidence needed to assemble your submission package alongside your regulatory counsel.

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Custom SaMD Solutions

At a Glance