What FDA pathway will we need?

It depends on risk and predicate availability — 510(k), De Novo, or PMA — or the product may fall under enforcement discretion or be exempt. We classify early and plan the pathway before heavy build.

IEC 62304 is the international standard for medical-device software lifecycle processes. We apply it — with ISO 14971 risk management — so development, verification, and maintenance are structured and auditable.

Do you handle cybersecurity documentation?

Yes. We build to FDA premarket cybersecurity expectations — threat modeling, a software bill of materials (SBOM), and security controls — as part of the submission package.

FDA Software as a Medical Device lifecycle overview

FDA SaMD Compliance

FDA SaMD compliant software development

For software that meets a medical-device definition, we engineer to the IMDRF/FDA Software as a Medical Device framework — risk classification, IEC 62304 lifecycle, verification and validation, and the traceable documentation a submission demands.

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Our compliance approach

We treat SaMD as a regulated product lifecycle, not a feature. From intended-use and risk classification onward, we apply IEC 62304 software lifecycle processes, ISO 14971 risk management, and design controls with full traceability — so verification, validation, and documentation build continuously toward a defensible regulatory pathway.

Framework

A structured, lifecycle-first approach to SaMD — classifying risk, standing up the quality system, and building with the traceability a submission requires.

Classification & Intended Use

We define intended use, classify the SaMD risk category against the IMDRF framework, and determine the likely FDA pathway.

Quality & Risk Planning

We tailor an IEC 62304 lifecycle and ISO 14971 risk-management plan to your device's software safety class.

Design Controls & Traceability

We implement design controls with requirements-to-test traceability, verification, and validation evidence throughout development.

Submission Support

We assemble the design history and technical documentation and support your regulatory pathway (510(k), De Novo, or exemption).

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Lera Health

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Our Process

Lifecycle-first delivery

A repeatable, evidence-driven lifecycle that captures classification, risk, verification, and validation continuously — so the design history file is ready when the submission is.

Intended Use & Risk Classification

We define intended use and classify SaMD risk (IMDRF categories I–IV), setting the software safety class and pathway.

Quality System & Lifecycle Setup

We stand up IEC 62304 lifecycle processes and ISO 14971 risk management with design-control gates.

Design, V&V & Traceability

We build with requirements traceability, verification, and validation evidence captured continuously in the design history file.

Documentation & Submission

We compile technical documentation and support the appropriate FDA pathway and a post-market surveillance plan.

Lifecycle & risk
architecture

Safety and security engineered across the device lifecycle — IEC 62304 processes, ISO 14971 risk controls, cybersecurity per FDA premarket guidance, and full requirements-to-test traceability.

FDA SaMD lifecycle and risk architecture overview

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Lera Health: compliant health platform

Related proof of regulated-grade delivery: for Lera Health we built a testing-to-insights workflow with traceable data handling and clinical rigor — the same discipline a SaMD lifecycle and design history file demand.

Our relevant experience

What makes us stand out!

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Frequently Asked Questions

If it's intended to diagnose, treat, prevent, or inform clinical decisions, it may meet the SaMD definition. We assess intended use against FDA and IMDRF criteria to determine whether — and how — it's regulated.

Plan your SaMD pathway

Tell us your product's intended use, and we'll classify the risk and map an IEC 62304 lifecycle to the right FDA pathway.