Software as a medical device,ready for review.

Know where your 510(k) software package stands, from CDS determination and IEC 62304 documentation to 524B cybersecurity and AI validation, and what to fix first.

Alenvo App

Readiness

90%

Sample: NeuroPulse AI

Evidence coverage

93%

Referenced evidence

Completeness

100%

Requirements answered

Confidence

97%

Evidence-backed

Critical blockers

SBOM not available for a cyber device

eSTAR preparation

Software
Cybersecurity

Supported today

FDA Traditional 510(k) for non-IVD, software-only medical devices, including AI-enabled software.

Not yet supported

De Novo and PMA scoring, IVD software, software in a hardware device, EU MDR and the EU AI Act. These are flagged for review, not scored.

01What we review

Five domains FDA software review depends on

Classification and pathway

Device determination, the four statutory non-device CDS criteria, product code, predicate and intended use.

Software lifecycle

Basic or Enhanced documentation level, architecture, SRS, design specification, V&V and unresolved anomalies, aligned to IEC 62304.

Risk and usability

ISO 14971 software risk, IEC 62366-1 usability and performance validation against the intended use.

Cybersecurity

For cyber devices under FD&C Act 524B: threat model, SBOM, vulnerability management plan and security testing.

AI and machine learning

Only when your software uses AI: dataset independence, subgroup performance, transparency and an optional PCCP.

What is SaMD readiness?

Software as a medical device (SaMD) is software intended for a medical purpose that is not part of a hardware device. Most SaMD reaches the US market through a 510(k), which shows substantial equivalence to a legally marketed predicate and is cleared, not approved. FDA expects software documentation scaled to risk, a risk management file, validation against the intended use and, for software that can connect to the internet, the cybersecurity content required by section 524B, including an SBOM.

SaMD Readiness applies the approach behind our Device Readiness product to software, without hardware topics such as biocompatibility or sterility.

Common questions

What does SaMD Readiness support today?: FDA Traditional 510(k) submissions for non-IVD software as a medical device. It is in pilot. De Novo and PMA, IVD software, software in a hardware device, Special and Abbreviated 510(k), EU MDR and the EU AI Act are flagged for regulatory review rather than scored.
What if my software may be non-device clinical decision support?: The setup asks the four criteria in FD&C Act 520(o)(1)(E). If all four are met, Alenvo does not produce a readiness score and recommends confirming the determination with regulatory counsel.
How do Basic and Enhanced documentation levels work?: FDA's 2023 software guidance replaced the old level of concern. Enhanced documentation applies when a software failure could present a probable risk of death or serious injury. Alenvo adds the Enhanced-only requirements, such as the software design specification, when you choose Enhanced.
Do I need a PCCP?: No. A Predetermined Change Control Plan is optional and only relevant if you plan to change an AI model after clearance without a new 510(k). Alenvo never penalizes you for not having one.
Does Alenvo predict FDA clearance?: No. It shows readiness, evidence coverage, assessment completeness and confidence as four separate figures so your regulatory, quality and engineering experts can act faster. It does not build or submit your eSTAR.