Methodology
What Aletia Index assesses, what's built today, and what's coming. Sections are labelled by current state so it's clear what you can rely on now and what's still in progress.
1) Structured Assessment
BuiltEvery device in the Index is anchored to a canonical Aletia identifier and tracked across jurisdictions. We surface the regulatory posture from primary sources — FDA 510(k) and De Novo authorisations, MHRA PARD registrations, EU MDR clearances via EUDAMED — and reconcile multiple identifiers (K-numbers, NCT numbers, MHRA IDs, CE certificates) onto a single device record.
The Index is queryable today by specialty, jurisdiction, lifecycle stage, and PCCP authorisation status. Each device has a permanent URL with structured metadata for indexing and citation.
2) Evidence Signals
In progressIndependent clinical assurance reviews against a 10-Point Assurance Checklist covering claim–evidence traceability, validation design (population, setting, endpoints), performance reporting (metrics, uncertainty, subgroup performance), and representativeness.
Reviews are conducted by Aletia's clinical team and result in the Aletia Verified badge. The badge cannot be self-assigned. Reviews are in progress; verified devices will surface as those reviews land, and the methodology behind each checkpoint will be published alongside the first cohort.
3) Lifecycle Transparency
PlannedIndicators for change control and versioning visibility, post-market monitoring signals, safety reporting pathways, and interoperability disclosures. The goal is to make it visible whether a device is being maintained — not just whether it was once cleared.
Source data for this layer (FDA adverse event reports, MHRA field safety notices, PCCP modification tracking) is partially ingested; the synthesis and display layer is the next workstream after Evidence Signals lands.
4) Regulatory professionals and Notified Bodies
DisclosureAletia plans to surface vetted regulatory professionals and Notified Bodies contextually, matched to the filter state a user is engaging — specialty, jurisdiction, lifecycle stage, and specialist work-type (PCCP authoring, conformity assessment, post-market surveillance).
Listed professionals will pay for inclusion. Specialism claims will be vetted against verifiable work product before listing and re-validated annually. Placements are editorially separate from Aletia's clinical assessments of devices — listing or non-listing of a professional has no influence on how a device is reviewed, ranked, or surfaced.
Pricing, the full vetting protocol, and the appeal pathway for declined applications will be published here when the directory launches.