Rosenbound is structured around the regulatory frameworks that govern its buyers: 21 CFR § 3060 for the 2026 PV ship, 21 CFR Part 11 ALCOA+ for the audit ledger, the FDA RWE Framework + PRINCIPLED for the methodology, the FDA 7-step AI credibility framework for documentation, the EU AI Act for European deployment, and the 510(k) + PCCP pathway for the post-2027 physician SaMD.
The pharmacovigilance triage product satisfies all four exemption criteria: (i) for a healthcare professional, (ii) advisory/supporting not directing a clinical decision, (iii) intended to enable the professional to independently review the basis for the recommendation, (iv) supported by appropriate references. No 510(k) required for ship in 2026.
The audit module satisfies the eleven sub-requirements of § 11.10 (validation of systems, accurate copies, record retention, system-access controls, audit trail, sequence-of-events, authority checks, etc.) by architectural design rather than operator configuration.
The flagship FDA RWE guidance directly motivates the five-method pentagon + Rosenbaum-Γ sensitivity bound as the right shape for an observational submission. Data-quality, transparency, and provenance expectations map onto the Cohort DSL + Cognitive Validation Report + reproducibility certificate.
Data-quality, traceability, and provenance expectations from this guidance map directly onto the Cohort DSL, the Cognitive Validation Report (which blocks ingestion of incoherent data), the cohort + data hash on every study, and the hash-chained audit ledger.
States explicitly: "Identifying and addressing the presence of confounding and other forms of bias is critical… planned sensitivity analyses to assess the robustness of study findings." Calls for "assessment of unmeasured confounding factors."
Prescribes "a plan for robustness assessments including deterministic sensitivity analyses, quantitative bias analyses, and net bias evaluation." Rosenbound's sensitivity pentagon + Γ-bound is exactly this class of instrument.
The TARGET reporting statement centers Hernán-style target-trial emulation for observational studies. Rosenbound's Studies module includes a target-trial protocol scaffold with explicit guards against immortal-time bias.
Names "bias, confounding, data quality" as central concerns. DARWIN EU (>140 studies/year from 2025) is EMA's primary RWE pathway.
Seven steps: (1) define the question of interest → (2) define the context of use (COU) → (3) assess model risk → (4) credibility-assessment plan → (5) execute → (6) document → (7) adequacy determination. Critically, this applies to the drug/biologic (pharma/RWE) path, not only devices — we structure documentation around COU and model risk for the PV and RWE products today, not for a future SaMD.
Auto-generated TRIPOD+AI-aligned model card on every Study — intended use, training data provenance, performance metrics, calibration, fairness assessment, model maintenance plan.
PCCP has three components: Description of Modifications, Modification Protocol, Impact Assessment. Available for 510(k), De Novo, and PMA pathways.
Pre-Submission to discuss substantial-equivalence claim with FDA reviewers ahead of formal 510(k) filing. Identifies the predicate device, refines the intended-use statement, and de-risks the clinical-validation requirements.
Per FDA's program page (Dec 31, 2025), CDRH/CBER have granted 1,246 Breakthrough Device designations with only 185 Marketing Authorizations. A 2024 JAMA Internal Medicine analysis found only 12.2% of designated devices (127 of 1,041) reached authorization — modest 510(k) acceleration.
AI used for diagnosis, CDS, triage, or patient monitoring is high-risk. Phased dates: prohibitions + AI-literacy applied Feb 2025; GPAI rules Aug 2025; most high-risk obligations Aug 2, 2026; Article 6(1) (AI embedded in CE-marked MDR/IVDR devices) applies Aug 2, 2027. The November 2025/February 2026 Digital Omnibus proposal may push standalone high-risk to Dec 2, 2027 and product-embedded to Aug 2, 2028 — monitor but do not rely on the delay.
Watch the product walkthrough at rosenbound.ai — three moments that define the platform: the Cognitive Validation Report refusing incoherent data, the live Γ-bound sensitivity visualization, and the reproducibility certificate generated on every study. The full platform stays gated for Founding Partners.
Watch the preview →
pip install rosenbound
— Official Python SDK for programmatic access: cohort upload, sensitivity-bounded study runs, and reproducibility certificate retrieval. Apache 2.0; Pydantic v2 typed; py.typed for IDE autocomplete + mypy. Platform access gated by Bearer token + RBAC + tenant scoping — the SDK is open, the audit substrate is not.
The Founding Partner Program includes a vendor-security packet (BAA, DPA, MSA templates, one-page security overview, SOC 2 Type I status, pen-test result) pre-prepared and ready for legal review. Designed to fast-track the vendor-onboarding process that typically stalls pharma deals for 4–8 weeks.